FDA Medical devices recall ·
BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm… recall
- Recall number
- Z-3202-2026
- Date
- (initiated July 30, 2026)
- Company / brand
- Howmedica Osteonics Corp.
325 Corporate Dr, Mahwah, NJ, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12,156 US
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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)
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3202-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.