Howmedica Recalls Scorpio Receded Metal Backed Patella Implants
Howmedica Osteonics Corp. is recalling specific Scorpio knee implant components due to aged polyethylene material that may cause 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 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 is classified as FDA Class II and involves a risk-of-harm product (orthopaedic implant) where potential harms like revision surgery and pain are described, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific lots of the SCORPIO RECESSED METAL BACKED 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 being issued because the aged polyethylene material has the potential for elevated levels of oxidation. This condition may result in increased wear of the implant, leading 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 had these specific implant components installed should contact their orthopaedic surgeon or healthcare provider to discuss the recall and determine if any further evaluation or action is necessary. The affected product codes and lot numbers are listed in the official FDA recall notice.
The recalled product
- Product
- SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 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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