- Recalling firm
- Howmedica Osteonics Corp.
- 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.
- Affected products (lot / model / serial)
- 5612-P-411 UDI-DI 07613327601893 Lot 360958 5612-P-413 UDI-DI 07613327602012 Lot 354573
- Units affected
- 12,156 US
- Distribution pattern
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Firm location
- Mahwah, NJ, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3198-2026
- Recall initiated
- July 30, 2026
- FDA classification date
- September 16, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99558
- Last updated on HTM Vibe
- September 29, 2026