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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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