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BIOMET MICROFIXATION, INC

Last updated September 17, 2026

Information

Country: US
Address: 1520 Tradeport Dr, Jacksonville, FL, 32218
Website: zimmerbiomet.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(904)741-4400
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 1032347
DUNS Number: 046189866

Catalogue (11790)

Page 2 of 236

Device	Model / Reference	Registries	Class	Status
Sternalock® Blu System	73-0006	FDA UDI	Class II	Active
Htr-Pmi	PM619554	FDA UDI	Class II	Active
2.0 Lactosorb System	915-2104	FDA UDI	Class II	Active
"2.4mm" System	91-2416	FDA UDI	Class II	Active
Walterlorenz™ Surgical Assist Arm	WAL409	FDA UDI	Class I	Active
Pectus System	PT-2016	FDA UDI	Class II	Active
Pectus System	PT-1934	FDA UDI	Class II	Active
Allogenix	02-3102	FDA UDI	Class II	Unknown
Pectus System	PS-0905	FDA UDI	Class II	Active
Htr-Pmi	PM617452	FDA UDI	Class II	Active
2.0 Lactosorb System	SP-2117	FDA UDI	Class II	Active
Pectus System	PS-1000	FDA UDI	Class II	Active
Pectus System	PT-3127	FDA UDI	Class II	Active
Pectus System	PT-3875	FDA UDI	Class II	Active
Pectus System	PT-3607	FDA UDI	Class II	Active
2.0mm System	SP-3081	FDA UDI	Class II	Unknown
Pectus System	PT-4387	FDA UDI	Class II	Active
Pectus System	PT-3895	FDA UDI	Class II	Active
Sterile Trac System 12 Pack	25-1015-12	FDA UDI	Class II	Active
Pectus System	PT-3626	FDA UDI	Class II	Active
Thinflap System	91-6604-EA	FDA UDI	Class II	Unknown
Pectus System	PT-2242	FDA UDI	Class II	Active
Pectus System	PS-1769	FDA UDI	Class II	Active
Pectus System	PT-3693	FDA UDI	Class II	Active
TraumaOne	SP-3447	FDA UDI	Class II	Active
Htr-Pmi	PM619948-A	FDA UDI	Class II	Active
Htr-Pmi	PM618872	FDA UDI	Class II	Active
Htr-Pmi	PM618250	FDA UDI	Class II	Active
Htr-Pmi	PM620373	FDA UDI	Class II	Active
Pectus System	PS-1081	FDA UDI	Class II	Active
Pectus System	PT-1873	FDA UDI	Class II	Active
2.0mm System	SP-3129-R	FDA UDI	Class II	Unknown
1.5mm System	01-7345	FDA UDI	Class II	Active
Pectus System	PT-4851	FDA UDI	Class II	Active
Pectus System	PS-1924	FDA UDI	Class II	Active
"2.0mm" System	01-8091	FDA UDI	Class II	Active
Htr-Pmi	PM621158-A	FDA UDI	Class II	Active
Htr-Pmi	PM619986	FDA UDI	Class II	Active
Pectus System	PT-3215	FDA UDI	Class II	Active
Pectus System	PT-3050	FDA UDI	Class II	Active
Htr-Pmi	PM620561	FDA UDI	Class II	Active
Pectus System	PS-0848	FDA UDI	Class II	Active
Traumaone System	72-2052	FDA UDI	Class II	Unknown
Htr-Pmi	PM617638	FDA UDI	Class II	Active
Traumaone System	SP-2330	FDA UDI	Class II	Unknown
Pectus System	PS-1943	FDA UDI	Class II	Active
Htr-Pmi	PM618046	FDA UDI	Class II	Active
2.0mm System	01-7694	FDA UDI	Class I	Active
Pectus System	PS-1249	FDA UDI	Class II	Active
Htr-Pmi	PM618743	FDA UDI	Class II	Active

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FDA Recalls (62)

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
Apr 11, 2017	Z-2073-2017	—	terminated	Part of the number on the tray lid differ from the part number on the base.
Jun 13, 2016	Z-2751-2016	—	terminated	Potential sterility deficiency.
Aug 6, 2015	Z-0136-2016	—	terminated	The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Aug 6, 2015	Z-0137-2016	—	terminated	The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Oct 17, 2014	Z-0513-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0519-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0512-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0514-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0509-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0518-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0520-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0511-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0517-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0516-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0515-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0522-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0510-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Oct 17, 2014	Z-0521-2015	—	terminated	Laser etching on the parts is wider and deeper than the conditions previously validated.
Sep 20, 2013	Z-2566-2014	—	terminated	Product mix occurred prior to final package and labeling process.
Nov 23, 2011	Z-0843-2012	—	terminated	Biomet Microfixation, Inc., Jacksonville, FL recalled their SternaLock Blu Implant Tray on 11/23/11, model numbers 73-1300 through 73-1302 due to the possibility of an inaccurate reading on the Screw Measuring Area. If used incorrectly, the screw measuring area inside the SternaLock Blu Implant Tray, could lead to the improper selection of a screw 2mm longer than needed.
Nov 15, 2011	Z-1323-2012	—	terminated	On 11/15/2011 Biomet Microfixation, Jacksonville, FL initiated a recall of their Acticort Heat/Contouring Pen, Model #915-3100, Lot #861200. Product is incorrectly labeled
Aug 18, 2011	Z-0012-2012	—	terminated	On 09/18/2011, Biomet Microfixation, Jacksonville, FL, recalled their SP-2411, Rubber Band, Lot 307850 because it was labeled and sold as "LATEX FREE" although it contains "LATEX". The firm's HHE identified this as a potential high health risk to the patients or end users with latex allergies.
Jul 8, 2011	Z-0447-2012	—	terminated	Biomet Microfixation, Inc., Jacksonville, FL, recalled their IQ Intelligent Device, 72-1000 due to failure of the front bit sensor to detect the correct bit that is installed. When a screw is inserted with the device in drill mode, it is possible for the screw or bone to strip.
Nov 8, 2010	Z-0836-2012	—	terminated	On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes
Nov 8, 2010	Z-0835-2012	—	terminated	On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes
Oct 8, 2010	Z-2852-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.
Oct 8, 2010	Z-2851-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.
Oct 8, 2010	Z-2850-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.
Oct 8, 2010	Z-2849-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling TMJ System OnPoint Scope Procedure Kit REF 24-3050; TMJ System ArthroSimplicity Kit REF 922070 & 24-4050; TMJ System InnerVue Scope Procedure Kit REF 922090. The OnPoint Scope Kits and ArthroSimplicity Kits contain Chloraprep Swabsticks that do not contain any warnings regarding the use of the product on eyes, ears or mouth.
Aug 31, 2010	Z-0108-2011	—	terminated	Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).
Jul 28, 2010	Z-2385-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y).
Jun 25, 2010	Z-2779-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling part number 01-6577, 2.0x7 mm Fossa X-drive screws, 5 pack, lot # 233270. This product is being recalled due to the possibility that the pack may have contained another part, 01-6581 2.0x11 mm Fossa x-drive screws, 5 pack.
Jun 25, 2010	Z-2392-2010	—	terminated	The forceps insulation may have cracks or breaks in the insulation that may cause burns to patients when used.
May 17, 2010	Z-2873-2011	—	terminated	On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17, 2010.
Apr 26, 2010	Z-1286-2012	—	terminated	On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.
Apr 7, 2010	Z-0823-2012	—	terminated	Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546.
Apr 7, 2010	Z-0822-2012	—	terminated	Biomet Microfixation, Inc., Jacksonville, FL recalled Part # 24-6546, 45mm Left Standard Mandible and Part # 24-6646, 45mm Left Standard Offset Mandible due to a lot of 24-6246 being etched & labeled as 24-6646 and the reverse, a lot of 24-6646 being etched and labeled as 24-6546.
Mar 17, 2010	Z-2206-2010	—	terminated	Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.
Mar 15, 2010	Z-2913-2011	—	terminated	Biomet Microfixation, Jacksonville, FL is recalling Center Drive Blade, 2.0, Model Number 01-9047, Lot # 064980. Product is non-conforming (blades do not retain screws).
Jan 15, 2010	Z-1319-2010	—	terminated	The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.
Nov 6, 2009	Z-0538-2010	—	terminated	The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).
Oct 6, 2009	Z-1151-2010	—	terminated	Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.
Oct 5, 2009	Z-1943-2010	—	terminated	Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.
Sep 15, 2009	Z-0489-2010	—	terminated	Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.
Sep 15, 2009	Z-0490-2010	—	terminated	Biomet Microfixation is recalling LactoSorb Self Drilling Adjustable Tap Model Numbers 915-2075 Lot # 064350 and 915-2185 Lot # 885580. The two lots identified have a new style stop and an old style tap; they are not compatible, as the depth etchings do not line up correctly. Depending on the tap (1.5mm VS 2.0mm) you may drill too shallow or too deep.
Mar 20, 2009	Z-1323-2009	—	terminated	This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. Implantation of foreign materials can result in an inflammatory response or allergic reaction.
Feb 19, 2009	Z-0169-2010	—	terminated	Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor , i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material.
Feb 16, 2009	Z-1949-2009	—	terminated	Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450 and JC1002. The drills may be color-banded blue instead of brown. The color is a visual aid in determining what system the drill goes with. The blue indicates the drill is for the 2.0mm system. The brown indicates the drill is to be used for our 2.3mm system. The drill is etched and labe
Jan 9, 2009	Z-0533-2010	—	terminated	Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ
Jan 9, 2009	Z-0532-2010	—	terminated	Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ
Jan 9, 2009	Z-0534-2010	—	terminated	Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ
Jan 9, 2009	Z-0530-2010	—	terminated	Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ
Jan 9, 2009	Z-0531-2010	—	terminated	Biomet Microfixation, Inc. is recalling their OnPoint TMJ Kit (Part Numbers 24-3050, 24-3055) and Arthrosimplicity TMJ Arthocentesis Kit (Part Numbers 922070, 922090, 922075). These two kits contain a BD sterile disposable 60 ml Luer-Lok syringe, Part number 309653 which is under recall by Becton Dickinson (Recall Number Z-2347-2008). Becton Dickinson has determined that unit package seal integ
Oct 24, 2008	Z-0415-2009	—	terminated	Fiber optic cable is missing from the Frederick's Converse Retractor Lot # 042408D08.
Aug 6, 2008	Z-0865-2009	—	terminated	Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
Aug 6, 2008	Z-0864-2009	—	terminated	Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
Aug 6, 2008	Z-0866-2009	—	terminated	Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
Aug 6, 2008	Z-0867-2009	—	terminated	Biomet Microfixation is recalling the Lactosorb Endobrow Lift Complete, Office Fixation Kit, 1.5/IMF Small Office Set and IMF Set trays containing instruments associated with the Lactosorb and IMF systems. The finished trays were packaged and shipped to facilities without the instructions for use and without the single use symbol on the packaged tray label.
Jul 11, 2008	Z-0282-2009	—	terminated	The packaging for the 91-2416, 2.4X16MM HT X-DRIVE SCREW, Lot 493200 actually contained the 99-6577, 2.0X7MM FOSSA X-DRIVE SCREW.
May 21, 2008	Z-0906-2009	—	terminated	The Biomet Microfixation Obwegeser Ramus Clamp, Wide Right 01-7996 were incorrectly etched as the left part number 01-7997.
Apr 16, 2008	Z-1871-2008	—	terminated	The working tips of the Stella Osteotomes are thicker than specification.
Mar 19, 2008	Z-1872-2008	—	terminated	The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).