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.
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 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.
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.
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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