Biomet Arcos Hip Implant Component Recalled for Potential Fretting Corrosion
Biomet is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body components due to potential fretting corrosion at the inner taper joint that could cause device failure and require revision surgery.
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: This is a risk-of-harm orthopedic implant with a specific, material hazard (fretting corrosion potentially causing device failure requiring surgical intervention). The source does not report confirmed injuries, fitting the rubric criterion for Score 3: risk-of-harm products where injury has not been reported.
Plain-English summary
Biomet, Inc. is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM (Item Number 11-301321, Lot 881730) due to potential fretting corrosion at the inner taper connection. The metal components could experience wear caused by movement between surfaces under stress, potentially leading to device failure within the body.
If device failure occurs, the affected patient may require revision surgery to remove and replace the implant. The recalled devices were distributed nationwide throughout the United States.
Patients with this implant component should contact their orthopedic surgeon to determine whether they may be affected and discuss appropriate monitoring or follow-up care. Healthcare providers can identify affected patients using the provided lot number and device identification information.
The recalled product
- Product
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
- Manufacturer
- Biomet, Inc.
- Hazard
- fretting-corrosion
- device-failure
- surgical-intervention-required
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers/UDI : 881730 (01)00880304474314(17)310324(10)881730
Distribution
Distributed nationwide across the United States.
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