Knee Replacement Component Recalled Due to Material Oxidation Risk
Howmedica Osteonics is recalling Scorpio NRG Tibial Brg Insert Assembly knee replacement components due to potential oxidation of raw materials over 5 years of age, which could affect material properties.
What this means for you
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 FDA Class II recall involves a documented risk of material degradation in an orthopedic implant component where no illnesses or injuries have been reported, fitting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Howmedica Osteonics Corp. is recalling Scorpio NRG Tibial Brg Insert Assembly components (Part Number 82-2-0908), which are used in knee replacement surgery. The affected product lot numbers are 42874701, 42912101, and 42995601.
The recall is due to potential oxidation of UHMWPE (ultra-high molecular weight polyethylene) raw material that is over 5 years of age. Oxidation can affect the material properties of the implant component.
The affected components were distributed nationwide and internationally to Argentina, Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Korea, Latin America, Mexico, Poland, Sweden, Switzerland, Taiwan, the United Kingdom, the Netherlands, Austria, Finland, Germany, Ireland, Hong Kong, New Zealand, Norway, and Spain.
Healthcare providers who received these components should immediately stop using the affected lot numbers. Patients who received implants from these lot numbers should consult with their healthcare provider regarding any necessary follow-up evaluation.
The recalled product
- Product
- Scorpio NRG Tibial Brg Insert Assy -Intended for knee replacement Part Number: 82-2-0908
- 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 (3)
- GTIN: 04546540400734 Lot Numbers: 42874701
- 42912101
- 42995601
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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