Biomet France S.a.r.l.
FDA adverse event reports naming Biomet France S.a.r.l. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOMET FRANCE S.A.R.L..
- Total reports
- 2,724
- Deaths
- 43
- Injuries
- 968
- Malfunctions
- 1,713
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Bone Cement, AntibioticMBB1,555
- Bone CementLOD384
- Bone Grafting Material, SyntheticLYC176
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI144
- Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedLZO75
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH66
- Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedKWS53
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA51
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH30
- Dispenser, CementKIH23
Recent recalls
- 2015-06-10TerminatedNonconforming Material/Component
The Optigun Ratchet is a hand-held cement gun for use with Optivac. The Optigun Ratchet is used to deliver bone cement from the Optivac.
The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the pin, and may necessitate revision surgery if the pin falls into the surgical site and is not detected.
Monitor Biomet France S.a.r.l. automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.