Howmedica Recalls Orthopaedic Implants Due to Potential UHMWPE Oxidation
Howmedica is recalling specific orthopaedic implant components made with aged UHMWPE material that may oxidize, potentially leading to increased wear and device failure.
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 implant) where injury has not yet been reported, and the agency classification is Class II, which aligns with the 'High' severity criteria for potential harm without confirmed adverse events.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components, including tibial inserts and glenoid components, manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The affected devices were produced using raw material that was aged in excess of five years. The recall covers 12,156 units distributed in the United States and internationally, including Canada, LATAM, Europe, Asia Pacific, and South Africa.
The recall is being issued because the aged UHMWPE material has the potential for elevated levels of oxidation. This oxidation may result in increased wear of the implant, which can lead to hazards such as excessive wear debris, material fragments, a fractured device, or a disassociated device. Potential harms associated with these failures include the need for revision surgery, pain, and inflammation.
Healthcare providers and patients should identify affected devices by checking the specific catalog numbers and lot numbers listed in the official recall notice. If a patient has one of these implants, they should contact their healthcare provider to discuss the potential risks and necessary monitoring or intervention.
The recalled product
- Product
- DURACON XL ANGLED TIB INS 11/14MM C-M064-1-300 SELF-PRESSURIZING GLENOID SIZE 8 C-M062-6-800 C-M062-7-500 C-M063-2-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-000 SHOULDER - GLENOID #11 5361-6111 SHOULDER - GLENOID #5 5361-6105 SHOULDER…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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