Knee Replacement Component Recalled Due to Raw Material Oxidation Risk
Howmedica Osteonics Corp. is recalling a SCORPIO TOTAL KNEE prosthesis component because UHMWPE raw material over 5 years old may have elevated oxidation levels affecting material properties and implant performance. Consumers with this implant should contact their physician for guidance.
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 Class II recall involves a risk-of-harm orthopedic implant component with potential material degradation. No illnesses or injuries have been reported, and the hazard is theoretical based on material property concerns, meeting the rubric criterion for High severity.
Plain-English summary
Howmedica Osteonics Corp. is recalling the SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 (Part Number 73-0110), a component used in total knee replacement procedures. The recall affects 61 units distributed in the United States and 46 units distributed to multiple countries internationally, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Mexico, and others.
The affected lot numbers are 79E0, 274P, WEKJ, LH82, and 33ND. The company determined that some units were manufactured using UHMWPE (ultra-high-molecular-weight polyethylene) raw material over 5 years old. This aged material has the potential for elevated oxidation levels.
Oxidation within UHMWPE can negatively impact material properties, which could affect the durability and performance of the prosthetic implant. No injuries or illnesses related to this issue have been reported.
If you have received this product, consult your physician or orthopedic surgeon for guidance. Healthcare providers can evaluate whether further assessment or action is needed for your specific implant.
The recalled product
- Product
- SCORPIO TOTAL KNEE MEDIALIZED DOME PATELLA-SZ #11 -Intended for knee replacement Part Number: 73-0110
- 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 (5)
- GTIN: 07613327050288 Lot Numbers: 79E0
- 274P
- WEKJ
- LH82
- 33ND
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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