Knee replacement patella component recalled due to material oxidation risk
Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components manufactured from UHMWPE raw material over 5 years of age, which may develop elevated oxidation affecting material properties.
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 medical device recall for a structural orthopedic implant component. Potential material oxidation could degrade implant properties and performance. No injuries or adverse events have been reported, but the risk to joint replacement structural integrity qualifies as High severity.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO RECESSED PATELLA knee replacement components (Part Number 3044-0026). The recalled units were manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material over 5 years of age.
The age of the raw material creates potential for elevated oxidation levels to develop. Oxidation in UHMWPE can affect the material's structural properties and performance. No adverse events or patient injuries have been reported related to this issue.
The recall affects 94 units in the United States and 131 units distributed to countries worldwide including Canada, Europe, Asia, and Latin America. Patients who have received this implant should contact their healthcare provider to determine whether their knee replacement is affected.
This Class II recall (FDA Recall Number Z-0869-2024) was issued to mitigate the potential risk of material degradation in the knee replacement component.
The recalled product
- Product
- SCORPIO RECESSED PATELLA- Intended for Knee Replacement Part Number: 3044-0026
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
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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