Arcos Modular Revision Hip System Cone Bodies Recalled for Device Failure Risk
Biomet, Inc. is recalling 21 units of Arcos Modular Revision Hip System Standard Cone Prox Bodies due to risk of fretting corrosion and device failure that may require 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: This is an FDA Class II recall for a risk-of-harm orthopedic device. While the hazard (fretting corrosion and device failure) is serious and could require surgical intervention, no illnesses or injuries have been reported to date, and the harm is described as potential rather than actual. This fits the Score 3 criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Biomet, Inc. is recalling the Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM (Item Number 11-301302) due to risk of fretting corrosion and potential device failure in vivo.
The recalled component (21 units total) has been distributed nationwide in the United States. The affected lot numbers are 626540 and 679320.
Fretting corrosion in the inner taper of the cone body could potentially lead to device failure, which may require surgical intervention to address. No injuries or illnesses have been reported to date.
Patients who have received this device should contact their healthcare provider or Biomet directly if they have concerns. Healthcare providers should review patient records to identify affected implants using the provided lot numbers.
The recalled product
- Product
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 60 MM Item Number: 11-301302
- Manufacturer
- Biomet, Inc.
- Hazard
- fretting-corrosion
- device-failure
Distribution
Distributed nationwide across the United States.
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