Knee replacement bearing insert recalled due to material degradation risk
Howmedica Osteonics Corp. is recalling Scorpio-Flex knee bearing inserts made with material over 5 years old that may develop oxidation affecting performance. Affected patients should contact their physician if they experience knee problems.
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 medical device with no reported illnesses or injuries. This is an implantable orthopedic device where potential material degradation has not yet resulted in documented injury, meeting the rubric criterion for Score 3: risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Scorpio-Flex Total Knee P-S Tibial Bearing Insert Assembly (Part Number 72-16-0908) is being recalled. This component is used in knee replacement surgery.
Howmedica Osteonics Corp. discovered that some units were manufactured using ultra-high-molecular-weight polyethylene (UHMWPE) raw material that was over 5 years old. This aged material has the potential to develop elevated oxidation levels, which can impact the material's properties and performance.
The recall affects 5 units in the United States and additional units distributed to 19 countries worldwide. The affected lot number is 42968601. Patients with this implant should contact their physician or the manufacturer to determine if they are affected and discuss any necessary follow-up.
The recalled product
- Product
- Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0908
- 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 (1)
- GTIN: 07613154020638 Lot Numbers: 42968601
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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