Z-3203-2026 Class II Ongoing
FDA device recall Z-3203-2026 was initiated by Howmedica Osteonics Corp. on July 30, 2026 and is designated Class II. Reason for recall: 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 m… The recall status is ongoing. Affected quantity: 12,156 US.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12,156 US
Product Description
SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
Code Information
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