Biomet Recalls Vanguard 360 Femoral Boss Reamers Due to Sizing Defect
Biomet is recalling 461 Vanguard 360 Femoral Boss Reamers because they were manufactured oversized and may not fit into mating components.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. No injuries or illnesses are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 461 units of the Vanguard 360 Femoral Boss Reamer (Catalog Number 32-488474). The recall affects specific lot numbers and additional scope lots identified in the agency records.
The recall was initiated because the instruments were manufactured oversized relative to the design specifications. As a result, the reamer may not fit properly into the mating component during use.
The affected products were distributed to healthcare facilities in 34 U.S. states, as well as to international locations including Korea, Japan, Puerto Rico, the UK, Chile, New Zealand, Australia, and Canada. Healthcare providers should stop using the affected reamers and contact Biomet for instructions on return or replacement.
The recalled product
- Product
- Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
- Manufacturer
- Biomet, Inc.
- Affected units
- 461
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Catalog Number: 32-48847 4 Lot Numbers: 022120
- 022180
- 162530
- 232460
- 475500 and 475510. 699240
- 793350
- 793570 Additional Scope: 065030
- 095780
- 164290
- 235870
- 253670
- 273630
- 308620
- 418970
- 420030
- 421210
- 570460
- 585260
- 619690
- 708240
Distribution
Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · manufacturing defect
See all →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12