Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.
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: The recall involves a risk-of-harm product (orthopaedic implants) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components, including knee inserts and patellae, manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. The affected devices were distributed worldwide, including in the United States, Canada, LATAM, Europe, Asia Pacific, and South Africa.
The recall is due to the potential for elevated levels of oxidation in the aged material. This oxidation may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured devices, or disassociated devices. Potential harms associated with these hazards include revision surgery, pain, and inflammation.
Patients who have received these specific implant components should contact their healthcare provider for evaluation and guidance. The recall covers 12,156 units in the United States.
The recalled product
- Product
- ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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