Biomet Microfixation, Inc
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000001169 FEI 1032347
- Devices
- 14,177
- Registrations
- EUDAMEDFDA
- FDA recalls
- 62
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI, FDA recalls
What Biomet Microfixation, Inc makes
Biomet Microfixation, Inc. manufactures orthopaedic and craniofacial fixation devices, including non-bioabsorbable plates and screws for cranial and facial bone stabilization, as well as cranioplasty sheets for reconstructive surgery. The company also produces surgical tools like reusable fluted drill bits and sterilization containers for medical instruments. Additionally, it supplies systems for pectus excavatum correction, such as funnel chest remodelling bars.
The portfolio includes devices classified under FDA’s Class I, Class II, and Class III categories, all listed in the FDA’s Unique Device Identifier (UDI) database. The company is based in the United States.
Catalogue
Search and filter all 14,177 devicesShowing 1-50 of 14,177
Company details
- EUDAMED SRN
- US-MF-000001169
- FDA FEI number
- 1032347
- DUNS number
- 046189866
- EUDAMED status
- Active
- EUDAMED registered name
- Biomet Microfixation
- EUDAMED abbreviated name
- Biomet Microfixation, LLC
- Registered address
- 1520, Tradeport Drive, 32218, Jacksonville, United States
- Website
- labeling.zimmerbiomet.com/
- Phone
- +1 904 741 4400
- PRRC contact
- Jennifer Everett
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 13 May 2031
BSI Group The Netherlands B.V. 2797 1 certificate
- MDR 726882 Active
Quality management system EU MDR
- Issued
- 16 Sep 2026
- Expires
- 13 May 2031
- Reason
- Add device or group
FDA recalls
FDA recall records list 62 recalls initiated by BIOMET MICROFIXATION, INC, the earliest on 2008-03-19 and the most recent on 2017-04-11. By recorded status: 62 terminated. The reasons filed fall into these groups: labeling or instructions for use, sterility or contamination, packaging, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 11 Apr 2017 Z-2073-2017 Class II Terminated Part of the number on the tray lid differ from the part number on the base.
2016
- 13 Jun 2016 Z-2751-2016 Class II Terminated Potential sterility deficiency.
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- 13 Jun 2016 Z-2751-2016 Class II Terminated Potential sterility deficiency.
2015
- 6 Aug 2015 Z-0136-2016 Class II 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.
- 6 Aug 2015 Z-0137-2016 Class II 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.
2014
- 17 Oct 2014 Z-0509-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0510-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0511-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0512-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0513-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0514-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0509-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
Show the 25 most recent of 62 recalls
2014
- 17 Oct 2014 Z-0515-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0516-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0517-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0518-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0519-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0520-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0521-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0522-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
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- 17 Oct 2014 Z-0515-2015 Class II Terminated Laser etching on the parts is wider and deeper than the conditions previously validated.
2013
- 20 Sep 2013 Z-2566-2014 Class II Terminated Product mix occurred prior to final package and labeling process.
2011
- 23 Nov 2011 Z-0843-2012 Unclassified (pre-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.
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- 15 Nov 2011 Z-1323-2012 Unclassified (pre-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
- 18 Aug 2011 Z-0012-2012 Unclassified (pre-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.
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- 8 Jul 2011 Z-0447-2012 Unclassified (pre-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.
Full distribution text
- 23 Nov 2011 Z-0843-2012 Unclassified (pre-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.
2010
- 8 Nov 2010 Z-0835-2012 Unclassified (pre-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
- 8 Nov 2010 Z-0836-2012 Unclassified (pre-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
Frequently asked questions
How many devices does BIOMET MICROFIXATION, INC have in the registry?
The registry currently lists 14177 devices for BIOMET MICROFIXATION, INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOMET MICROFIXATION, INC's devices?
Among its 50 most recently registered devices, BIOMET MICROFIXATION, INC has devices listed in EUDAMED (50 devices).
What risk classes do BIOMET MICROFIXATION, INC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for BIOMET MICROFIXATION, INC's devices are Class I and Class IIb. Each device page shows its own class and authorisation.
Are there FDA recall records for BIOMET MICROFIXATION, INC?
FDA recall records list 62 recalls initiated by BIOMET MICROFIXATION, INC, the most recent initiated on 11 Apr 2017. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What EUDAMED certificates are recorded for BIOMET MICROFIXATION, INC?
EUDAMED lists 1 certificate for BIOMET MICROFIXATION, INC (quality management system) under MDR. The most recent was issued on 16 Sep 2026.
What are the newest devices from BIOMET MICROFIXATION, INC in the registry?
The most recently registered devices listed for BIOMET MICROFIXATION, INC include RIBFIX BLU™ SYSTEM, "2.4MM" SYSTEM, "2.7MM" SYSTEM and TRAUMAONE.