Official recall notice
FDA Recall: BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM
- Recall date
- 2026-09-23
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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
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