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DEPUY ORTHOPAEDICS, INC.

Last updated September 17, 2026

Information

Country: US
Address: 700 ORTHOPAEDIC DR., WARSAW, IN, 46582
Website: xx.xx
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)255-2500
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1818910
DUNS Number: 080506581

Catalogue (6454)

Page 1 of 130

Device	Model / Reference	Registries	Class	Status
PFC SIGMA Knee System	K182301	FDA 510(k)	Class II	Active
Endurance	2521-11-501	FDA UDI	Class I	Active
Sigma Aox	1961-92-062	FDA UDI	Class III	Active
Specialist	2999-64-460	FDA UDI	Class I	Active
Sigma Lcs High Performance	9505-02-303	FDA UDI	Class I	Active
Global Advantage	2128-56-010	FDA UDI	Class I	Unknown
Solution System	2108-54-000	FDA UDI	Class I	Active
Global Fx	2128-01-040	FDA UDI	Class I	Active
Attune	2999-65-375	FDA UDI	Class I	Active
Solution System	2108-39-000	FDA UDI	Class I	Active
Attune	2999-65-596	FDA UDI	Class I	Active
Pinnacle Altrx	1221-32-466	FDA UDI	Class II	Active
S-Rom	52-6524L	FDA UDI	Class III	Active
Solution System	1571-29-000	FDA UDI	Class II	Active
Pinnacle Altrx	1221-44-168	FDA UDI	Class II	Active
Duraloc	1220-36-554	FDA UDI	Class II	Active
Pinnacle	1217-98-440	FDA UDI	Class II	Active
Sigma	96-1333A	FDA UDI	Class I	Active
Specialist	86-5049	FDA UDI	Class I	Active
S-Rom	52-6678	FDA UDI	Class III	Active
Pinnacle	1217-98-498	FDA UDI	Class II	Active
Attune	2545-07-740	FDA UDI	Class I	Active
Sigma Rpf Aox	1961-91-021	FDA UDI	Class III	Active
Sigma	2024-62-200	FDA UDI	Class I	Active
Attune	2999-66-498	FDA UDI	Class II	Active
Solution System	2572-08-195	FDA UDI	Class I	Active
Attune	2999-66-484	FDA UDI	Class I	Active
Sigma	96-1352A	FDA UDI	Class I	Active
S-Rom	2576-08-218	FDA UDI	Class I	Active
Lcs Completion	2178-61-095	EUDAMEDFDA UDI	Class I	Active
Agility	1404-34-050	FDA UDI	Class II	Active
Global Fx	2128-01-035	FDA UDI	Class I	Active
Duraloc	1242-20-527	FDA UDI	Class II	Active
Attune	2999-65-859	FDA UDI	Class I	Active
Specialist	96-8407	FDA UDI	Class I	Active
Lcs Completion	2294-26-060	FDA UDI	Class I	Active
Duraloc	1242-24-527	FDA UDI	Class II	Active
Pinnacle Altrx	1221-44-164	FDA UDI	Class II	Active
Global Steptech	1130-44-995	FDA UDI	Class II	Active
Attune	2999-66-460	FDA UDI	Class II	Active
Pinnacle	1219-36-158	FDA UDI	Class II	Active
Pinnacle	1218-32-666	FDA UDI	Class II	Active
Pinnacle	1217-98-953	FDA UDI	Class II	Active
Pinnacle	1219-28-046	FDA UDI	Class II	Active
Pinnacle	1218-28-466	FDA UDI	Class II	Active
Pinnacle	2218-48-170	FDA UDI	Class I	Active
Duraloc	1220-28-450	FDA UDI	Class II	Active
Lcs Complete	1294-27-031	FDA UDI	Class III	Active
Lcs	1278-73-025	FDA UDI	Class III	Active
Global Steptech	1130-40-993	FDA UDI	Class II	Active

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FDA Recalls (100)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 12, 2024	Z-1456-2024	—	open, classified	Product incorrectly labelled.
Feb 15, 2023	Z-1265-2023	—	open, classified	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Feb 15, 2023	Z-1263-2023	—	open, classified	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Feb 15, 2023	Z-1267-2023	—	open, classified	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Feb 15, 2023	Z-1266-2023	—	open, classified	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Feb 15, 2023	Z-1264-2023	—	open, classified	The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
Jun 29, 2022	Z-1419-2022	—	open, classified	Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
May 18, 2022	Z-1375-2022	—	open, classified	The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
Mar 11, 2022	Z-1029-2022	—	terminated	System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
Jan 5, 2022	Z-0631-2022	—	terminated	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Jan 5, 2022	Z-0632-2022	—	terminated	May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
Dec 7, 2021	Z-0485-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0488-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0484-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0487-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0490-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0486-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0489-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Dec 7, 2021	Z-0483-2022	—	terminated	Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
Sep 9, 2021	Z-0074-2022	—	terminated	Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
Aug 10, 2021	Z-2396-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Aug 10, 2021	Z-2395-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Aug 10, 2021	Z-2394-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Aug 10, 2021	Z-2398-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Aug 10, 2021	Z-2399-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Aug 10, 2021	Z-2397-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Aug 10, 2021	Z-2400-2021	—	terminated	Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
Jul 1, 2021	Z-2348-2021	—	terminated	Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
May 7, 2021	Z-1845-2021	—	terminated	Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
Feb 22, 2021	Z-1315-2021	—	terminated	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Feb 22, 2021	Z-1316-2021	—	terminated	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Feb 22, 2021	Z-1314-2021	—	terminated	Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
Jan 8, 2021	Z-1103-2021	—	terminated	The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Dec 15, 2020	Z-0802-2021	—	terminated	Certain Pinnacle Cup devices may potentially exhibit an oversized "minor diameter", which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of "cross-threading". If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.
Jan 3, 2020	Z-1169-2020	—	terminated	The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
Sep 21, 2018	Z-1128-2019	—	terminated	There is the potential for debris/material to be found behind the O-rings in the neck trials.
Sep 21, 2018	Z-1129-2019	—	terminated	There is the potential for debris/material to be found behind the O-rings in the neck trials.
Sep 21, 2018	Z-1127-2019	—	terminated	There is the potential for debris/material to be found behind the O-rings in the neck trials.
Jul 18, 2018	Z-2949-2018	—	terminated	This unit may be missing the screw/collet Assembly
Jun 21, 2018	Z-2521-2018	—	terminated	Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and additional surgical procedure to correct. It may also result in an intraoperative fracture which could represent a surgical delay and additional procedures.
Apr 16, 2018	Z-1703-2018	—	terminated	There may be burrs on the extraction hole threads.
Apr 16, 2018	Z-1704-2018	—	terminated	There may be burrs on the extraction hole threads.
Dec 21, 2017	Z-1219-2018	—	terminated	The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
Nov 28, 2017	Z-1012-2018	—	terminated	The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was inverted during assembly to the body, which will cause the humeral stem to sit proud and may cause surgical delays.
Aug 31, 2017	Z-0834-2018	—	terminated	The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Aug 31, 2017	Z-0833-2018	—	terminated	The affected lots are being recalled because the epiphysis may not assemble to the stem, which may cause a surgical delay.
Jul 26, 2017	Z-0848-2018	—	terminated	Potential for Intra-operative breakage of driver tips
Jul 26, 2017	Z-0849-2018	—	terminated	Potential for Intra-operative breakage of driver tips
Jul 12, 2017	Z-0594-2018	—	terminated	Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
Jul 12, 2017	Z-0593-2018	—	terminated	Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH OFFSET STEM Collarless SIZE 14 (Part No. L20314 / Lot No. 5292130).
Jan 6, 2017	Z-2317-2017	—	terminated	Products were made outside of Quality System Regulation, and potentially outside of premarket submission (510k/PMA) for certain devices. The safety or effectiveness of these devices cannot be assured.
Nov 8, 2016	Z-0703-2017	—	terminated	DePuy Orthopaedics, Inc. is voluntarily recalling one lot of the LCS Complete Knee Revision System VVC Insert Small 22.5mm, due to the insert being manufactured outside of specifications, which prevents the insert from properly seating in the mating tibial tray.
Oct 25, 2016	Z-0650-2017	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary recall for all lots of the ACTIS Flex Reamers due to the instruments breaking and potentially leaving pieces in the patient.
Jan 8, 2016	Z-0787-2016	—	terminated	Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.
Sep 8, 2015	Z-0111-2016	—	terminated	DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.
Jun 12, 2015	Z-2145-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2140-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2141-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2144-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2137-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2142-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2143-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2138-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2139-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Jun 12, 2015	Z-2146-2015	—	terminated	Potential for the Balseal, a small wire spring coil located on the post feature of the ATTUNE Knee Tibial Articulation Surface Instruments used in trialing to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.
Mar 4, 2015	Z-1672-2015	—	terminated	The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
Mar 4, 2015	Z-1673-2015	—	terminated	The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patella is not resurfaced when compared to other unresurfaced PS implants. If the LCS COMPLETE RPS Knee System is implanted and the native patella is not resurfaced, the patient may experience patello-femoral pain, potentially requiring a secondary procedure.
Feb 23, 2015	Z-1357-2015	—	terminated	This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery and there is the potential for plastic pieces to be left in the patient.
Feb 11, 2015	Z-1246-2015	—	terminated	One lot of SMARTSET GHV Gentamicin Bone Cement is partially agglomerated . This may result in surgical delays while a replacement package of cement is retrieved and mixed.
Nov 12, 2014	Z-0908-2015	—	terminated	Use of excessive force when impacting may lead to intra-operative femoral fracture.
Nov 10, 2014	Z-0903-2015	—	terminated	ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Nov 10, 2014	Z-0905-2015	—	terminated	ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Nov 10, 2014	Z-0904-2015	—	terminated	ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Nov 10, 2014	Z-0953-2015	—	terminated	Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
Nov 7, 2014	Z-0825-2015	—	terminated	Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the
Oct 15, 2014	Z-0199-2015	—	terminated	Issuing a device correction because if the pin bushing is over loaded or inverted, there is the potential for partial or full displacement and fracture of the plastic around the pin bushing.
Sep 3, 2014	Z-0038-2015	—	terminated	Specific lots are being recalled due to the potential for the tabs to break, leaving fragments in the patient.
Aug 27, 2014	Z-0061-2015	—	terminated	The small extraction peg of the Charnley Pin Retractor and Handle set is breaking from the pin.
Jun 3, 2014	Z-2082-2014	—	terminated	The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Jun 3, 2014	Z-2083-2014	—	terminated	The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Jun 3, 2014	Z-2084-2014	—	terminated	The product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming.
Mar 28, 2014	Z-1437-2014	—	terminated	Urgent Device Correction notifications are being sent to USA distributors with follow-up to surgeons concerning updated surgical techniques stressing the possibility of the shoulder pin guide breaking and potentially being left in the patient.
Feb 24, 2014	Z-1205-2014	—	terminated	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p
Feb 24, 2014	Z-1206-2014	—	terminated	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa
Feb 24, 2014	Z-1207-2014	—	terminated	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa
Feb 24, 2014	Z-1208-2014	—	terminated	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the pa
Feb 24, 2014	Z-1204-2014	—	terminated	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the p
Feb 24, 2014	Z-1203-2014	—	terminated	DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the
Dec 9, 2013	Z-1077-2014	—	terminated	Knee implant femoral devices were found to have anomalous microstructure. Porosity and the presence of blocky carbides, within the cobalt chrome part, can decrease the overall fatigue strength. This decrease in strength could cause implants to fracture under what would normally be acceptable loads.
Nov 18, 2013	Z-0412-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0415-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0417-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0418-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0413-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0416-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0414-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0422-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0421-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0419-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.
Nov 18, 2013	Z-0423-2014	—	terminated	DePuy Orthopaedics, Inc. is issuing a voluntary device correction of the HP M.B.T. Keel Punch Knee Instrument because of the potential for tabs on the connection end to fracture and be left in the patient.