Biomet Microfixation
FDA adverse event reports naming Biomet Microfixation as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOMET MICROFIXATION.
- Total reports
- 8,263
- Deaths
- 21
- Injuries
- 6,095
- Malfunctions
- 1,888
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Plate, Fixation, BoneHRS2,307
- Plate, BoneJEY1,777
- Joint, Temporomandibular, ImplantLZD1,759
- Screw, Fixation, BoneHWC791
- Elevator, Surgical, DentalEMJ576
- Drills, Burrs, Trephines & Accessories (Simple, Powered)HBE322
- Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial ReconstructionKKY133
- Motor, Surgical Instrument, Ac-PoweredGEY59
- BenderHXW56
- Plate, Cranioplasty, Preformed, Non-AlterableGXN49
Recent recalls
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Lft Stand Off Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
- 2014-12-16TerminatedSoftware Design Change
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Laser etching on the parts is wider and deeper than the conditions previously validated.
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