Biomet Microfixation
1520 Tradeport Dr, Jacksonville, FL, US
Registered product codes
150 product codes
Recent MDR events
8,349 on file
- LACTO 14MM RAPIDFLAP CLAMPJul 30, 2026Malfunction0001032347-2026-00222
- RIBFIX BLU 10 HOLE STRT PLTJul 30, 2026Injury0001032347-2026-00223
- TMJ MED RT FOSSA COMPJul 27, 2026Injury0001032347-2026-00220
- 50MM RT STANDARD MANDJul 27, 2026Injury0001032347-2026-00221
- TMJ SM RT FOSSA COMPJul 21, 2026Injury0001032347-2026-00218
- 45MM RT STANDARD MANDIBULARJul 21, 2026Injury0001032347-2026-00219
- TMJ SM LFT FOSSA COMPJul 20, 2026Injury0001032347-2026-00214
- 45MM LFT STANDARD MANDJul 20, 2026Injury0001032347-2026-00215
- UNKNOWN TMJ MANDIBLEJul 20, 2026Injury0001032347-2026-00216
- UNKNOWN TMJ FOSSAJul 20, 2026Injury0001032347-2026-00217
Recalls
62 on file
- TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗ - TerminatedDec 16, 2014
Laser etching on the parts is wider and deeper than the conditions previously validated.
View FDA record ↗
Compliance history
Matched by FEI 1032347.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 4, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Mar 4, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 803.50(a)(2)Mar 4, 2025
Individual Report of Malfunction
- 21 CFR 820.100(a)Mar 4, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Mar 4, 2025
Lack of or inadequate complaint procedures
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.