Howmedica Osteonics Corp. recalls BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640
- Recalling company
- Howmedica Osteonics Corp.
- Product
- BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Reason
- 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 – may cause temporary or medically reversible health consequences
- Recall date
- Jul 30, 2026
- Reported
- Sep 23, 2026
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
- Status
- Ongoing
- Quantity
- 12,156 US
- Lot / codes
- C-M113-1-301 UDI-DI 07613327590074 Lot MH621A C-M113-5-600 No UDI Lot 194593 C-M063-5-800 No UDI Lot RX06358A
- Company location
- Mahwah, NJ
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3202-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3202-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.