Howmedica Osteonics Corp.: SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BI
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Howmedica Osteonics Corp.
- Product
- SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 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
- 78-5-0910 UDI-DI 07613327366006 Lot 30582401 6074-4022 UDI-DI 07613327031775 Lots 2M5NTY LH25R5 M36N83 6074-4322 UDI-DI 07613327031805 Lot W40E3T 6074-4422 UDI-DI 07613327031812 Lot R84K20
- Product quantity
- 12,156 US
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mahwah
- State
- NJ
- Country
- United States
- Event id
- 99558
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