Biomet Arcos Hip Prosthesis Recalled Due to Device Failure Risk
Biomet is recalling certain Arcos Modular Revision Hip System components due to risk of device failure and fretting corrosion. Affected patients may require 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: FDA Class II medical device recall. The product poses risk of device failure requiring surgical intervention, but no illnesses or injuries have been reported. Per the rubric, theoretical hazards without reported injury are scored at most 3.
Plain-English summary
The Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM, manufactured by Biomet, Inc., is being recalled due to the potential for device failure.
The recalled component could develop chatter in the inner taper and fretting corrosion, potentially leading to device failure in vivo. If device failure occurs, revision surgery may be necessary to replace the affected implant.
The recall affects specific lots (626490 and 679210) of the Arcos prosthesis that were distributed nationwide. Patients who have received this implant should contact their healthcare provider to discuss their individual situation.
The recalled product
- Product
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 60 MM Item Number: 11-301301
- Manufacturer
- Biomet, Inc.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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