Knee replacement implant recalled due to material oxidation risk
Howmedica Osteonics is recalling SCORPIO TS TIB INSERT knee implants (Lot Numbers 482LM8, HH43K7) manufactured with aged UHMWPE material. The raw material is over 5 years old and may develop oxidation that could affect the implant's material properties.
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 critical medical device (knee implant) with potential for harm. The hazard—UHMWPE material oxidation—could affect implant performance. No illnesses or injuries have been reported, so the severity is capped at High per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB INSERT knee replacement implants (Part Number 72-4-7514, Lot Numbers 482LM8 and HH43K7) manufactured with UHMWPE raw material that is over 5 years of age.
UHMWPE (ultra-high-molecular-weight polyethylene) raw material aged beyond 5 years has the potential to develop elevated levels of oxidation. When oxidation occurs in UHMWPE, it can impact the material's properties, potentially affecting device performance.
The recalled implants were distributed nationwide and internationally. Patients who have received these implants should contact their orthopedic surgeon or the manufacturer for guidance.
The recalled product
- Product
- SCORPIO TS TIB INSERT -Intended for knee replacement Part Number: 72-4-7514
- 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: 07613327034820 Lot Numbers: 482LM8
- HH43K7
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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