Knee Replacement Insert Recalled Due to Potential Material Oxidation
Howmedica Osteonics is recalling Scorpio-Flex knee prosthesis inserts due to potential oxidation in UHMWPE raw material over 5 years old, which could impact 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 for a medical device used in joint replacement where material oxidation could potentially impact device properties. No illnesses or injuries have been reported, making this a precautionary recall based on potential rather than confirmed risk.
Plain-English summary
Howmedica Osteonics Corp. is recalling Scorpio-Flex Total Knee Prosthesis Tibial Bearing Insert Assembly components (Part Number 72-16-0910) used in knee replacement procedures.
The recall was initiated because UHMWPE (ultra-high-molecular-weight polyethylene) raw material that is over 5 years old has the potential for elevated levels of oxidation. Oxidation can impact the material's properties, potentially affecting device performance.
Approximately 9 units were distributed in the United States. Internationally, units were distributed to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Patients with this implant should contact Howmedica Osteonics Corp. for guidance. The affected lot number is 43103101. No illnesses or injuries related to this issue have been reported to date.
The recalled product
- Product
- Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 9
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: 07613154020645 Lot Numbers: 43103101
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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