Reported Aug 27, 2014 · Terminated
Vanguard 360 Femoral Boss Reamer, Label: REF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET…
Biomet, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989
Is this the product you have?
- Vanguard 360 Femoral Boss Reamer
- LabelREF 32-488474 VANGUARD 360 1NSTRUMENT FEMORAL BOSS REAMER NON-STERILE, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE P.O. BOX 587 WARSAW, IN 46581 USA
- Lot codes and dates
- Catalog Number32-48847 4
- Lot Numbers
022120022180162530232460475500 and 475510. 699240793350793570
- Additional Scope
065030095780164290235870253670273630308620418970420030421210570460585260619690708240711430726490816160896810929690953540968950
- Amount recalled
- 461
Where it was sold
Why it was recalled
The Vanguard 360 Femoral Boss Reamers were manufactured oversized to the print. The instrument may not fit into the mating component.
This product could cause temporary or reversible health problems — stop using it.
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