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MEDTRONIC SOFAMOR DANEK, INC.

United States·US-MF-000023095

Last updated May 24, 2026

What MEDTRONIC SOFAMOR DANEK, INC. makes

The company manufactures spinal fixation hardware, including non-bioabsorbable bone screws, metallic interbody fusion cages, and internal spinal fixation rods and connectors. Their portfolio also includes spinal implant trials, reusable instrument trays, orthopaedic knives, and internal spinal distractors. These devices are designed for spinal surgery and orthopaedic procedures.

The devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The company operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Medtronic Sofamor Danek, Inc. manufacture?

Medtronic Sofamor Danek, Inc. specializes in spinal fixation hardware, including non-bioabsorbable bone screws, metallic spinal interbody fusion cages, and internal spinal fixation systems like rods and connectors. Their portfolio also covers spinal implant trials, reusable instrument trays for surgical use, orthopaedic knives, and internal spinal distractors. These devices are primarily designed for spinal surgery and orthopaedic procedures.

Where is Medtronic Sofamor Danek, Inc. based?

The company is headquartered in the United States. This location aligns with its regulatory submissions and compliance requirements for devices marketed globally, including those listed in the FDA’s Unique Device Identifier (UDI) database.

Which regulatory registries list devices manufactured by Medtronic Sofamor Danek, Inc.?

Devices from Medtronic Sofamor Danek, Inc. are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for spinal fixation hardware, including screws, rods, cages, and surgical instruments, by assigning a standardized identifier to each device.

How are devices from Medtronic Sofamor Danek, Inc. classified under FDA regulations?

The company’s devices fall under FDA’s Class I and Class II classifications. Class I generally includes low-risk devices like reusable instrument trays, while Class II covers moderate-risk products such as spinal fixation systems (e.g., screws, rods, and cages) that require special controls to ensure safety and effectiveness. Classification determines regulatory oversight and submission requirements.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: United States
Address: 1800 , Pyramid Place, Memphis, United States
Website: medtronic.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(800)633-8766
PRRC Contact: Alison Webster
EUDAMED SRN: US-MF-000023095
FDA FEI Number: —
DUNS Number: 830350380

Catalogue (38519)

Page 1 of 500

Device	Model / Reference	Registries	Class	Status
CD HORIZON® Fenestrated Screw Set	55751026575	FDA UDI	Class II	Active
CD HORIZON® Spinal System	X1010677	FDA UDI	Class II	Unknown
CD HORIZON® Spinal System	X0312237	FDA UDI	Class II	Active
CD HORIZON® Spinal System	X0809502	FDA UDI	Class II	Active
TSRH® Spinal System	83585359	FDA UDI	Class II	Active
CD HORIZON® Spinal System	5454220	FDA UDI	Class II	Active
CD HORIZON® Spinal System	55410008030	FDA UDI	Class II	Unknown
CD HORIZON® Spinal System	55410001570	FDA UDI	Class II	Unknown
ZEVO™ Anterior Cervical Plate System	G7783519	FDA UDI	Class II	Active
CAPSTONE® Spinal System	X0613914	FDA UDI	Class II	Active
Medtronic Reusable Instruments	EX1210145	FDA UDI	Class I	Active
TSRH® Spinal System	X0209443	FDA UDI	Class II	Active
Medtronic Reusable Instruments	X07318142	FDA UDI	Class I	Active
Medtronic Reusable Instruments	EX06124019	FDA UDI	Class I	Active
TSRH® Spinal System	88946550	FDA UDI	Class II	Active
PYRAMID® +4 Anterior Lumbar Plate System	9874041	FDA UDI	Class II	Active
PIVOX™ Oblique Lateral Spinal System	2171255	FDA UDI	Class II	Active
CD Horizon™ ModuLeX™ Spinal System	55901506030	FDA UDI	Class II	Active
CD HORIZON® Spinal System	X0311330	FDA UDI	Class II	Active
CD HORIZON® Spinal System	55840007560	FDA UDI	Class II	Active
Medtronic Reusable Instruments	8959011	FDA UDI	Class I	Active
Medtronic Reusable Instruments	EX0111089	FDA UDI	Class I	Active
CD HORIZON® Spinal System	X0809101	FDA UDI	Class II	Unknown
VERTEX® Reconstruction System	X0209555	FDA UDI	Class II	Active
Vertex Reconstruction System	G7750087	FDA UDI	Class II	Active
CD HORIZON® Spinal System	7020750	FDA UDI	Class II	Active
CD HORIZON® Spinal System	74646040	FDA UDI	Class II	Active
CD Horizon™ ModuLeX™ Spinal System	559200099	FDA UDI	Class II	Active
CD HORIZON® SOLERA® VOYAGER™ Spinal System	55850011011	FDA UDI	Class II	Active
CD HORIZON® Spinal System	X0809326	FDA UDI	Class II	Active
CD HORIZON® Spinal System	54840018555	FDA UDI	Class II	Active
TSRH® Spinal System	88934530	FDA UDI	Class II	Active
CD HORIZON® SOLERA® Spinal System	651003095	FDA UDI	Class II	Active
PIVOX™ Oblique Lateral Spinal System	2172450	FDA UDI	Class II	Active
CD HORIZON® Spinal System	X1013211	FDA UDI	Class II	Unknown
TSRH® Spinal System	X8301529	FDA UDI	Class II	Unknown
CD HORIZON® Spinal System	99414535	FDA UDI	Class II	Unknown
CD HORIZON® SOLERA® VOYAGER™ Spinal System	55750019570	FDA UDI	Class I	Active
CD HORIZON® Spinal System	X1207085	FDA UDI	Class II	Unknown
VERTEX® Reconstruction System	6958948	FDA UDI	Class II	Active
CD HORIZON® Spinal System	778001118	FDA UDI	Class I	Active
TSRH® Spinal System	88946525	FDA UDI	Class II	Active
CD HORIZON® Spinal System	75644035	FDA UDI	Class II	Active
ANATOMIC PEEK PTC Cervical Fusion System	5030341	FDA UDI	Class II	Active
Divergence® Anterior Cervical Fusion System	G6624015	FDA UDI	Class II	Active
Medtronic Reusable Instruments	EX1110046	FDA UDI	Class I	Active
VERTE-STACK® Spinal System	X0309183	FDA UDI	Class II	Active
CD HORIZON® Spinal System	X0710768	FDA UDI	Class II	Unknown
CD HORIZON® Spinal System	X0708355	FDA UDI	Class II	Active
TSRH® Spinal System	855011L75	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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
Sep 16, 2025	Z-0580-2026	—	open, classified	Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.
Sep 26, 2023	Z-0166-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Sep 26, 2023	Z-0162-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Sep 26, 2023	Z-0165-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Sep 26, 2023	Z-0167-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Sep 26, 2023	Z-0164-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Sep 26, 2023	Z-0163-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Sep 26, 2023	Z-0161-2024	—	open, classified	Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have been released with potential non-conformances in the outer Tyvek pouch.
Jul 31, 2023	Z-2524-2023	—	open, classified	The incorrect product labeling was applied to the product indicating the wrong size of product.
Jul 12, 2023	Z-2363-2023	—	open, classified	Incorrect Laser Marking - Solera Awl Tip Tap
Jun 6, 2023	Z-2118-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Jun 6, 2023	Z-2117-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Jun 6, 2023	Z-2121-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Jun 6, 2023	Z-2120-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Jun 6, 2023	Z-2122-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Jun 6, 2023	Z-2123-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Jun 6, 2023	Z-2119-2023	—	open, classified	There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. Implants have a central cavity that allows them to be packed with autogenous bone graft and/or allograft bone graft comprised of cancellous and/or Corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.
Feb 16, 2023	Z-1411-2023	—	open, classified	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Feb 16, 2023	Z-1412-2023	—	open, classified	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Feb 16, 2023	Z-1409-2023	—	open, classified	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Feb 16, 2023	Z-1413-2023	—	open, classified	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Feb 16, 2023	Z-1410-2023	—	open, classified	Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Feb 8, 2023	Z-1327-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1324-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1326-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1323-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1333-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1334-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1325-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1331-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1328-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1329-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1330-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Feb 8, 2023	Z-1332-2023	—	open, classified	Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.
Nov 19, 2021	Z-1574-2023	—	open, classified	Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.
Sep 2, 2021	Z-0085-2022	—	terminated	Engraving on implants may not match what is listed on the pouch labels.
Sep 2, 2021	Z-0086-2022	—	terminated	Engraving on implants may not match what is listed on the pouch labels.
Apr 27, 2021	Z-1797-2021	—	terminated	Product is impacted by a thread profile defect due to a manufacturing issue.
Mar 17, 2021	Z-1440-2021	—	terminated	The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Mar 17, 2021	Z-1439-2021	—	terminated	The shelf box identifies a small device actually contains a large device, and the shelf box identifying a large device actually contains a small device.
Jun 8, 2020	Z-2694-2020	—	terminated	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Jun 8, 2020	Z-2692-2020	—	terminated	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Jun 8, 2020	Z-2695-2020	—	terminated	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Jun 8, 2020	Z-2690-2020	—	terminated	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Jun 8, 2020	Z-2693-2020	—	terminated	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Jun 8, 2020	Z-2691-2020	—	terminated	Insertion difficulty of the probes. The probe was catching on a lip inside the hub of the cannula.
Apr 24, 2020	Z-2390-2020	—	terminated	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Apr 24, 2020	Z-2389-2020	—	terminated	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Apr 24, 2020	Z-2391-2020	—	terminated	Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.
Mar 26, 2020	Z-1941-2020	—	terminated	Nonconforming product; length of the product measured shorter than the labeled length.
Sep 27, 2018	Z-0440-2019	—	terminated	The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
Jul 9, 2018	Z-2603-2018	—	terminated	This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.
Mar 23, 2018	Z-1750-2018	—	terminated	Slot screw had an overall length of 15mm, but per the specification, the screw should have an overall length of approximately 17mm.
Mar 13, 2018	Z-1641-2018	—	terminated	The firm received complaints of drill bits breaking during use with the Prestige LP(TM) Cervical Disc System. Subsequent investigation demonstrated the interaction of the drill guide and the drill bit may lead to drill bit breakage.
Dec 22, 2017	Z-0566-2018	—	terminated	Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.
Dec 6, 2017	Z-0352-2018	—	terminated	Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.
May 17, 2017	Z-2247-2017	—	terminated	The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument. Using affected bone void filler may result in the injected cement being placed in a direction unintended by the surgeon.
Apr 13, 2017	Z-2047-2017	—	terminated	Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one bevel-tipped needle.
Feb 20, 2017	Z-1514-2017	—	terminated	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Feb 20, 2017	Z-1516-2017	—	terminated	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Feb 20, 2017	Z-1515-2017	—	terminated	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Feb 20, 2017	Z-1513-2017	—	terminated	The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
Jul 18, 2016	Z-2634-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2631-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2635-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2632-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2633-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2637-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2638-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jul 18, 2016	Z-2636-2016	—	terminated	The alpha total knee replacement components that may have not been passivated in accordance with the requirements of the job traveler.
Jan 13, 2015	Z-1057-2015	—	terminated	The product, labeled as containing, one bevel-tipped instrument and one diamond-tipped instrument, may contain either two bevel-tipped instruments or two diamond-tipped instruments.
Dec 3, 2014	Z-0952-2015	—	terminated	The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Jan 6, 2014	Z-0977-2014	—	terminated	Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2.5 cm x 5 cm.
Jan 3, 2014	Z-0866-2014	—	terminated	The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not allow proper mating between the Set Screw Retaining Drive and the set screw.
Aug 12, 2013	Z-2200-2013	—	terminated	One lot of the T8 Removal Head had incorrect hardness specification, which could result in the T8 Removal head failing during removal of the CD Horizon Spire and Spire Z Spinal System implant. There is a potential for tissue damage to occur and/or minor surgical delay to remove the remaining fragments of the tip.
May 28, 2013	Z-1595-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
May 28, 2013	Z-1589-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
May 28, 2013	Z-1592-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
May 28, 2013	Z-1593-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
May 28, 2013	Z-1590-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
May 28, 2013	Z-1591-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
May 28, 2013	Z-1594-2013	—	terminated	Kits contain a collagen sponge recalled by Integra due to possible elevated endotoxin levels resulting from a process deviation.
Aug 30, 2012	Z-0038-2013	—	terminated	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Aug 30, 2012	Z-0036-2013	—	terminated	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Aug 30, 2012	Z-0037-2013	—	terminated	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. An incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
Mar 13, 2012	Z-1442-2012	—	terminated	Drill stops may be bypassed when the device is used with powered drilling instruments.
Mar 13, 2012	Z-1443-2012	—	terminated	Drill stops may be bypassed when the device is used with powered drilling instruments.
Mar 13, 2012	Z-1444-2012	—	terminated	Drill stops may be bypassed when the device is used with powered drilling instruments.
Nov 30, 2011	Z-0464-2012	—	terminated	One screw may be longer then size etched on the screw.
Nov 30, 2011	Z-0465-2012	—	terminated	One screw may be longer then size etched on the screw.
Jul 12, 2011	Z-3044-2011	—	terminated	Screws are 5 mm longer than the size etched on the screw.
Jul 6, 2011	Z-2985-2011	—	terminated	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.
Jul 6, 2011	Z-2984-2011	—	terminated	Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws.
Jun 28, 2011	Z-2878-2011	—	terminated	Screws are longer then size etched on the screw.
Jun 28, 2011	Z-2874-2011	—	terminated	Screws are longer then size etched on the screw.
Jun 28, 2011	Z-2877-2011	—	terminated	Screws are longer then size etched on the screw.
Jun 28, 2011	Z-2875-2011	—	terminated	Screws are longer then size etched on the screw.
Jun 28, 2011	Z-2876-2011	—	terminated	Screws are longer then size etched on the screw.
Dec 7, 2009	Z-0606-2010	—	terminated	The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.
Dec 7, 2009	Z-0607-2010	—	terminated	The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.