OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic... recall (Howmedica Osteonics Corp.)
Medical deviceClass IIOngoing
Summary: Howmedica Osteonics Corp. is recalling OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 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.
What is being recalled
OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, LATAM, Europe, Asia Pacific, and South Africa.
How to tell if yours is affected
UDI-DI 07613327037883 Lot 13MFT
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-3196-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | July 30, 2026 |
| Reported | September 23, 2026 |
| Company | Howmedica Osteonics Corp. |
| Company location | Mahwah, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 12,156 US |
More recalls from Howmedica Osteonics Corp. · all medical device recalls · recalls from July 2026