Howmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components because aged polyethylene material may cause increased wear and 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm medical device where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for theoretical hazards without reported illness.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components, including SCORPIO + MOBILE BEARING PCS and SYSTEM ONE BIPOLAR 40MM, 43MM, and 44MM models. These devices are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) and were distributed worldwide, including in the United States, Canada, LATAM, Europe, Asia Pacific, and South Africa.
The recall is due to the use of 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. Consequences of this wear can 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, injuries, or fatalities associated with these devices. Consumers and healthcare providers should consult the FDA recall notice for specific lot numbers and UDI-DI codes to identify affected units.
The recalled product
- Product
- SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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