Howmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear and potential device failure.
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 (revision surgery, pain, inflammation), meeting the criteria for a Severe rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components, including acetabular cups, constrained inserts, and liners, manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material that was aged in excess of five years. The recall involves 12,156 units distributed in the United States and worldwide, including Canada, LATAM, Europe, Asia Pacific, and South Africa.
The affected devices have the potential for elevated levels of oxidation due to the age of the raw material. This oxidation may result in increased wear, which can lead to hazards such as excessive wear debris, material fragments, fractured devices, or disassociated devices. Potential harms associated with these issues include the need for revision surgery, pain, and inflammation.
The source text does not specify a particular action for consumers or patients, nor does it state if any illnesses or injuries have been reported. Healthcare providers and patients should refer to the official FDA recall notice for specific instructions on managing these implanted devices.
The recalled product
- Product
- ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL POLY CONSTRAINED INSERT 46MM 69-2246 ALL POLY CONSTRAINED INSERT 48MM 69-2248 ALL POLY CONSTRAINED INSERT 50MM 69-2850 ALL POLY CONSTRAINED INSERT 52MM 69-2852…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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