Knee Replacement Implant Component Recalled for Material Degradation Risk
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella components due to potential oxidation in raw materials over 5 years old. No illnesses have been 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 a Class II FDA recall of a structural orthopedic implant component. The hazard is material degradation from oxidation, which can compromise mechanical properties. No illnesses or injuries have been reported, keeping the severity at the maximum threshold of 3 for products with theoretical risk and no reported harm.
Plain-English summary
Howmedica Osteonics Corp. is recalling SCORPIO Total Knee Concentric Dome Patella-SZ #7 knee replacement components (Part Number 73-2710) due to a manufacturing defect involving raw material oxidation.
The UHMWPE (Ultra-High Molecular Weight Polyethylene) raw material used in production is over 5 years of age and has the potential for elevated oxidation levels. Oxidation within UHMWPE can impact its mechanical properties and potentially affect implant performance. This is a Class II recall.
Affected lot numbers are V25H, MD9E, 5MYL, H9T8, and 845P. Thirty-six units were distributed in the United States. The product was also distributed internationally to Argentina, Australia, Brazil, Canada, Chile, China, Columbia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, United Kingdom, Netherlands, and as of January 2024, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
The recalled product
- Product
- SCORPIO TOTAL KNEE CONCENTRIC DOME PATELLA-SZ #7 -Intended for knee replacement Part Number: 73-2710
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 36
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 (5)
- GTIN: 07613327033847 Lot Numbers: V25H
- MD9E
- 5MYL
- H9T8
- 845P
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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