Howmedica Recalls Scorpio Patella Implants Due to Polyethylene Wear Risk
Howmedica is recalling specific Scorpio patella implants because aged polyethylene material may cause excessive wear, leading to device failure and potential revision surgery.
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 in a medical implant that can lead to device fracture and the need for revision surgery, meeting the criteria for a Severe rating.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific lots of SCORPIO C-DOME and U-DOME patella orthopaedic implant components. The affected devices were manufactured using Ultra High Molecular Weight Polyethylene (UHMWPE) raw material that was aged in excess of five years. The recall covers 12,156 units distributed in the United States and internationally, including Canada, LATAM, Europe, Asia Pacific, and South Africa.
The recall is due to the potential for elevated levels of oxidation in the aged polyethylene material. This oxidation may result in increased wear, which can lead to hazards such as excessive wear debris, material fragments, a fractured device, or a disassociated device. Potential harms associated with these failures include the need for revision surgery, pain, and inflammation.
Patients who have received these specific implant components should contact their orthopaedic surgeon to discuss the recall and determine if any follow-up care or monitoring is necessary. Healthcare providers should verify the specific lot numbers and UDI-DI codes against the recall list to identify affected patients.
The recalled product
- Product
- SCORPIO C-DOME PATELLA 73-2710 73-2910 SCORPIO U-DOME PATELLA 73-3110 73-3508 73-3708 73-3710 73-3910 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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