SCORPIO TS Knee Implant Recall Due to Material Oxidation Risk
Howmedica is recalling SCORPIO TS knee implants made with raw material over 5 years old due to potential oxidation that could degrade the device's mechanical properties.
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 medical device recall involving risk of mechanical failure due to material degradation in an orthopedic implant. The source states no illnesses or injuries have been reported, and the hazard is based on potential oxidation, not confirmed adverse events. This fits the rubric criterion for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB INSERT knee replacement implants (Part Number 72-4-7521) due to a material aging issue.
The recalled implants were manufactured using UHMWPE (ultra-high molecular weight polyethylene) raw material over 5 years old. This material has the potential for elevated oxidation levels, which can impact the implant's mechanical properties and performance.
The affected devices were distributed nationwide in the United States and internationally, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. The specific lot recalled is VA0X4T.
The recalled product
- Product
- SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7521
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- material-degradation
- mechanical-failure
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 (1)
- GTIN: 07613327034837 Lot Numbers: VA0X4T
Distribution
Distributed nationwide across the United States.
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