Howmedica Recalls OMNIFIT Series I Acetabular Inserts Due to Material Wear
Howmedica Osteonics Corp. is recalling OMNIFIT Series I acetabular inserts because aged polyethylene material may cause excessive wear and device failure.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fractured or disassociated device) that can lead to significant injury requiring revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling OMNIFIT Series I acetabular inserts (Catalog No. 2001-2246) manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The recall involves 12,156 units distributed in the United States and internationally, including Canada, LATAM, Europe, Asia Pacific, and South Africa.
The affected devices were manufactured with UHMWPE raw material that was aged in excess of five years. This aging process has the potential to result in elevated levels of oxidation, which may lead to increased wear. Potential hazards include excessive wear debris, material fragments, fractured devices, or disassociated devices.
Potential harms associated with these defects include the need for revision surgery, pain, and inflammation. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 07613327037883 Lot 13MFT
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Howmedica Osteonics Corp.
See all →- HighHowmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
FDA (Devices) · 2026-09-23
- SevereHowmedica Recalls Aged Orthopaedic Implant Components Due to Wear Risk
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Triathlon Hinge Inserts Due to Material Aging
FDA (Devices) · 2026-09-23
- HighHowmedica Recalls Scorpio Receded Metal Backed Patella Implants
FDA (Devices) · 2026-09-23
Same hazard · material wear
See all →- HighEncore Medical Recalls RSP Impaction Fixtures Due to Material Wear
FDA (Devices) · 2017-03-15
- ModerateEncore Medical Recalls Turon Impaction Fixtures Due to Material Wear
FDA (Devices) · 2017-03-15
- HighEncore Medical Recalls Turon Shoulder Impaction Fixtures Due to Material Wear
FDA (Devices) · 2015-11-04
- ModerateEncore Medical Recalls Reverse Shoulder Prosthesis Stem Impaction Fixtures
FDA (Devices) · 2015-11-04