SCORPIO TS TIB INSERT Knee Replacement Components Recalled for Potential Material Degradation
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee replacement inserts manufactured with aging raw material. The material may develop elevated oxidation that could affect performance.
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 an FDA Class II recall with no reported injuries or hospitalizations. The hazard—potential oxidation and material property degradation in a knee implant—represents a risk-of-harm product where injury has not yet been reported, which scores as High (3) per the severity rubric.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB INSERT knee replacement components (Part Number: 72-4-7524). The recall involves units manufactured using ultra-high molecular weight polyethylene (UHMWPE) raw material that is over 5 years old.
The source indicates that UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within this material can impact its material properties, which could affect the implant's performance.
The recalled products have been distributed nationwide and in multiple foreign countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, South Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain. The affected lot numbers are V68WW1 and 93400601.
The recalled product
- Product
- SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7524
- Manufacturer
- Howmedica Osteonics Corp.
- Hazard
- oxidation
- material-degradation
- implant-performance-risk
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: 07613327034844 Lot Numbers: V68WW1
- 93400601
Distribution
Distributed nationwide across the United States.
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