Scorpio NRG Tibial Bearing Insert Assembly Recall Due to Material Oxidation Risk
Howmedica Osteonics Corp. is recalling Scorpio NRG Tibial Bearing Insert Assemblies manufactured with raw material over 5 years old, which may develop elevated oxidation affecting implant durability.
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: Material oxidation in orthopedic implants constitutes a risk-of-harm product with potential for serious complications. Per the FDA severity rubric, recalls of risk-of-harm medical devices where injury has not yet been reported score 3 (High).
Plain-English summary
Howmedica Osteonics Corp. is recalling specific batches of the Scorpio NRG Tibial Bearing Insert Assembly, a component used in knee replacement surgeries. The devices were manufactured using ultra-high molecular weight polyethylene (UHMWPE) raw material that exceeded 5 years of age at the time of manufacturing. Aged UHMWPE can develop elevated oxidation levels, which may impact the material's physical properties and potentially affect the long-term performance and durability of the implant.
The recall affects 4 units distributed in the United States and internationally, including Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, Spain, and the Netherlands. The affected lot numbers are 42912201 and 42961901.
Patients or healthcare providers who have implanted or received this device should contact Howmedica Osteonics Corp. or their healthcare provider for guidance and medical evaluation. Patients should not attempt device removal without proper medical consultation.
The recalled product
- Product
- Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0910
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 4
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: 04546540400741 Lot Numbers: 42912201
- 42961901
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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