Official recall notice
FDA Recall: OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant componen
- 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
UDI-DI 07613327037883 Lot 13MFT