Reported Oct 22, 2025 · Ongoing
BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD…
BioPro, 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: BioPro, Inc. · 2929 Lapeer Rd · Port Huron, MI · 48060-2558
Is this the product you have?
BioPro Femoral Head (Metal 2228323640) cobalt chromium
- and ceramic heads Part ID/Description18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9
- Lot codes and dates
- Part ID/ UDI-DIAll lots and serial numbers affected
18593M2091859318594M2091859419003M2091900319004M2091900419005M2091900519006M2091900619007M2091900719008M2091900819053M2091905319054M2091905419055M2091905519056M2091905619057M2091905719130M2091913019131M2091913119132M2091913219133M2091913319134M2091913419135M20919135
- Part ID/ UDI-DI
- Amount recalled
- 147 total
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
This product could cause temporary or reversible health problems — stop using it.
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