Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear, device fracture, or the need for revision surgery.
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 'High' severity criteria for potential harm without confirmed illness.
Plain-English summary
Howmedica Osteonics Corp. is recalling specific orthopaedic implant components, including acetabular inserts, tibial inserts, and bipolar components, 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, Latin America, Europe, Asia Pacific, and South Africa.
The recall is due to the potential for elevated levels of oxidation in the aged polyethylene material. This oxidation may result in increased wear, which can lead 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.
The source text does not specify the number of affected units, specific lot numbers, or reported illnesses. Consumers and healthcare providers should consult the FDA recall notice for specific product codes and instructions on how to manage the affected devices.
The recalled product
- Product
- ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW…
- Manufacturer
- Howmedica Osteonics Corp.
- Affected units
- 12,156
Distribution
Distributed nationwide across the United States.
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