Knee Replacement Implant Recalled for Potential Material Degradation Risk
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB knee replacement implants manufactured with aged raw material that may develop oxidation, potentially affecting 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—potential oxidation of aged UHMWPE material that could affect implant properties, but no adverse effects have been reported. This meets the 'High' criterion as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO TS TIB INSERT implants (Part Number 72-4-7518), which are used in knee replacement surgery. Approximately 5 units were distributed in the US, with additional units distributed to numerous countries including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, and others.
The recall concerns implants manufactured using UHMWPE raw material that was over 5 years of age. Extended storage of this material can lead to elevated oxidation levels, which may impact the material's properties and potentially affect implant performance over time.
Patients who received SCORPIO TS TIB implants with lot numbers 9P8360 or AK8393 may be affected. Healthcare providers and patients should contact Howmedica Osteonics Corp. or consult their physician regarding their implant, as the company has communicated the recall details to healthcare facilities. Implant removal may be considered based on individual patient circumstances and physician judgment.
The recalled product
- Product
- SCORPIO TS TIB INSERT. Intended for knee replacement Part Number: 72-4-7518
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 5
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: 07613327034813 Lot Numbers: 9P8360
- AK8393
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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