Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics recalls SCORPIO TS TIB INSERT knee replacement components manufactured with UHMWPE raw material over 5 years old, which may experience elevated oxidation affecting material properties. No injuries or illnesses have been reported.
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: This is a Class II FDA medical device recall involving an implanted structural component. Although no injuries or illnesses have been reported, the potential for material oxidation and degradation of structural properties represents a risk-of-harm scenario in an implanted medical device, meeting the rubric criterion for High severity.
Plain-English summary
Howmedica Osteonics Corp. has recalled SCORPIO TS TIB INSERT, a tibial component used in knee replacement surgeries. The recall affects units manufactured using UHMWPE (ultra-high molecular weight polyethylene) raw material that is over 5 years of age. This older material has the potential to develop elevated oxidation levels, which can affect the material's structural properties.
The recalled products have been distributed nationwide and internationally, including to Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the UK, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. The affected lot numbers are TN1746 and KK82WY.
No injuries or illnesses have been reported in connection with this recall. Patients or healthcare providers with questions should consult the FDA's official recall notice for detailed information and guidance.
The recalled product
- Product
- SCORPIO TS TIB INSERT -Intended for knee replacment Part Number: 72-4-7516
- 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 (2)
- GTIN: 07613327034806 Lot Numbers: TN1746
- KK82WY
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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