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.
What this means for you
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.
- Hazard
- oxidation
- material-degradation
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.
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