Howmedica Osteonics Corp.: SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured fro
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- Company / brand
- Howmedica Osteonics Corp.
- Product
- SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Reason / hazard
- Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Recall initiated
- 2026-07-30
- Code info
- 3045-0026 No UDI Lots 12WAHA 12WAHB HOHE HOVX 3045-0028 No UDI Lots 13VAW 13VAWA 3045-0030 No UDI Lots BIYIE HNZY 3045-0032 No UDI Lots BIYIH HOYK
- Product quantity
- 12,156 US
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mahwah
- State
- NJ
- Country
- United States
- Event id
- 99558
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