Biomet, Inc.
FDA adverse event reports naming Biomet, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: BIOMET, INC..
- Total reports
- 1,769
- Deaths
- 19
- Injuries
- 1,429
- Malfunctions
- 230
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
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH234
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH171
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI163
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY111
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA105
- Prosthesis, Hip, Hemi-, Acetabular, Cemented, MetalKWB102
- Orthopedic Manual Surgical InstrumentLXH68
- Bit, DrillHTW67
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH65
- Rod, Fixation, Intramedullary And AccessoriesHSB55
Recent recalls
- 2025-10-17Open, ClassifiedUnder Investigation by firm
BIOMET ZipTight, Acute AC Joint Implant, Single Ziploop , Model/Catalog Number: 904834; Fixation System for AC Joint Repair
There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop
- 2025-09-23Open, ClassifiedUnder Investigation by firm
Juggerknot Mini Soft Anchors, Model/Catalog Number: 912080
The outer carton box label is for the JuggerKnot 1.0mm Mini products. However, the products within the carton are JuggerKnot 1.4mm Short devices.
- 2024-11-15Open, ClassifiedProcess control
JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357
Firm received complaints reporting that guides were warped when pulled out of packaging. This issue may result in extension of surgery to find another product, or may lead to adverse local tissue reaction leading to surgical intervention.
- 2024-06-25Open, ClassifiedLabeling mix-ups
RingLoc Bi-Polar Hip System Acetabular Cup, 41 mm Outer Diameter - Used in hip hemi-arthroplasty Item Number: 11-165206
41 mm acetabular outer heads were potentially assembled with a 42 mm locking ring, may lead to joint instability leading requiring surgical intervention
- 2024-04-22Open, ClassifiedProcess change control
Vanguard Knee System AS Tibial Bearing / DCM ArCom, 12 MM X 75 MM; Model Number 189082. The product is placed into a foil pouch with protective packaging in the form of a polyurethane bag, and sealed closed (inner barrier). The inner barrier is then placed into a PETG tray and sealed with Tyvek lid stock (outer barrier). The sealed double barrier system is placed into a paperboard carton with an IFU and label/indicator dots applied to the carton.
Possible damage to the Vanguard Knee System AS Tibial Bearing caused during the manufacturing process.
- 2023-12-18Open, ClassifiedUnder Investigation by firm
Biolox Ceramic Option Head Zimmer 12/14 40mm -3, Item Number 00-8777-040-01
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
- 2023-12-18Open, ClassifiedUnder Investigation by firm
Biolox Ceramic Option Head Zimmer 12/14 40mm +0, Item Number 00-8777-040-02
One product complaint was received reporting that there was an incorrect adapter in the packaging. An adapter with neck length M/+0 was inside the product packaging, which should have contained an adapter with neck length S/-3.0. The difference in neck length may be recognized by the size (S or M) indicator on the device.
- 2023-11-21Open, ClassifiedDevice Design
Compress Device Segmental Anchor Plug, 10 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178400
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-21Open, ClassifiedDevice Design
Compress Device Segmental Anchor Plug, 12 MM -For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178402
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
- 2023-11-21Open, ClassifiedDevice Design
Compress Device Segmental Anchor Plug, 14 MM-For Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Item Number: 178404
Anchor plugs potentially have metal burrs in the transverse holes of the device, preventing the drill or pins from passing through, may result in extension of surgery
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