Knee implant component recalled due to potential material oxidation
Howmedica Osteonics is recalling SCORPIO RECESSED PATELLA knee implant components made from UHMWPE material over 5 years old that may develop elevated oxidation.
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: FDA Class II recall of an orthopedic implant component. UHMWPE is a critical structural material in knee implants, and elevated oxidation can degrade material properties and potentially affect implant performance. No illnesses or injuries reported. Classified as High under the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
The SCORPIO RECESSED PATELLA is a knee replacement component manufactured by Howmedica Osteonics Corp. The recall affects units made from UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is over 5 years of age.
UHMWPE material that is over 5 years old can develop elevated levels of oxidation. Oxidation can impact the material's properties, which could affect implant performance. The FDA has classified this as a Class II recall.
A total of 52 units were distributed in the United States, and 20 units were distributed to international markets including Canada, Mexico, Latin America, Europe, and Asia. Lot numbers affected include A59N, EP7J, and X79L.
Patients with this implant should consult their healthcare provider for guidance. Healthcare facilities should verify inventory against the provided lot numbers and coordinate with the manufacturer.
The recalled product
- Product
- SCORPIO RECESSED PATELLA- Intended for knee replacement Part Number: 3044-0028
- Manufacturer
- Howmedica Osteonics Corp.
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 (3)
- GTIN: 07613327033793 Lot Numbers: A59N
- EP7J
- X79L
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 58 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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