Howmedica Recalls Orthopaedic Implant Components Due to Material Aging
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing 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 (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed incidents.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components, including bearing and axle bushing assemblies, tibial inserts, and self-pressurizing glenoids. These devices were manufactured using Ultra High Molecular Weight Polyethylene (UHMWPE) raw material that was aged in excess of five years. The recall affects 12,156 units distributed in the United States and internationally.
The recall is due to the potential for elevated levels of oxidation in the aged polyethylene 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 failures include the need for revision surgery, pain, and inflammation.
Patients who have received these specific implant components should contact their healthcare provider to discuss the recall and determine if any action is necessary. The affected products are identified by specific catalog numbers and lot numbers listed in the official recall notice.
The recalled product
- Product
- BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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