Biomet Hip Implant Cone Bodies Recalled Due to Fretting Corrosion Risk
Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring surgical intervention.
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: FDA Class II device with potential for device failure and surgical intervention, but no reported illnesses or injuries. This is a high-risk product where injury has not yet been reported.
Plain-English summary
Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM (Item Number: 11-301311). A total of 22 units were distributed nationwide in the United States, with affected lot numbers 678930 and 880200.
The proximal cone bodies in this hip system could potentially develop chatter and fretting corrosion at the inner taper interface. This corrosion may lead to device failure that would require surgical intervention to address.
Surgeons and healthcare facilities that implanted this device should contact Biomet for information on patient monitoring, management options, or device replacement. Patients who have received this implant should contact their healthcare provider if they experience hip pain, instability, or other concerning symptoms.
The recalled product
- Product
- Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
- Manufacturer
- Biomet, Inc.
- Hazard
- fretting-corrosion
- implant-failure
Distribution
Distributed nationwide across the United States.
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