Howmedica Recalls Aged Orthopaedic Implant Components Due to Wear Risk
Howmedica is recalling 12,156 orthopaedic implant components made with aged polyethylene material. The aging may cause excessive wear, leading to device failure and potential need for revision surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, including the need for revision surgery.
Plain-English summary
Howmedica Osteonics Corp. is recalling 12,156 units of AXLE PIN ASSY LARGE ELBOW COBALT CHROME (Catalog No. C-M112-2-500) orthopaedic implant components. These devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material that was aged in excess of five years. The affected units are identified by UDI-DI Lot P22E159.
The recall is due to the potential for elevated levels of oxidation in the aged material, which may result in increased wear. This wear can lead to hazards such as excessive wear debris, material fragments, fractured devices, or disassociated devices. Potential harms associated with these failures include revision surgery, pain, and inflammation.
The affected devices were distributed worldwide, including the United States, Canada, Latin America, Europe, Asia Pacific, and South Africa. Patients who have received these implants should contact their healthcare provider to discuss the recall and determine if any action is necessary.
The recalled product
- Product
- AXLE PIN ASSY LARGE ELBOW COBALT CHROME Catalog No. C-M112-2-500 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)
- No UDI-DI Lot P22E159
Distribution
Distributed nationwide across the United States.
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