Knee replacement implant recalled for potential material oxidation
Howmedica Osteonics recalls SCORPIO TS TIB knee replacement inserts (lot TA21X9) manufactured from UHMWPE material over 5 years old due to potential elevated oxidation that could affect material properties. No injuries 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 an FDA Class II recall of a knee replacement implant with potential risk of material degradation. No injuries or illnesses have been reported. Per the rubric, risk-of-harm products where injury has not yet been reported receive a score of 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB INSERT knee replacement implants (part number 72-4-0321, lot number TA21X9) intended for use in knee replacement surgery.
The recall is due to the discovery that UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can impact the material's properties.
The affected products have been distributed nationwide in the United States and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, and the Netherlands. In January 2024, the distribution list was updated to include Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
No injuries or illnesses related to this issue have been reported to date. Patients and healthcare providers with these implants should contact Howmedica Osteonics Corp. for further information and guidance.
The recalled product
- Product
- SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-0321
- 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 (1)
- GTIN: 07613327034349 Lot Numbers: TA21X9
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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