FDA Recalls Biomet Hip Implant for Potential Fretting Corrosion
Biomet is recalling its Arcos Modular Revision Hip System Standard Cone Prox Body due to risk of fretting corrosion and device failure in the inner taper. Affected patients should consult their surgeon.
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: This FDA Class II recall involves a structural implant defect with potential for device failure requiring surgical intervention. It represents a risk-of-harm product where injury has not yet been reported, meeting the criterion for High severity.
Plain-English summary
Biomet, Inc. is recalling the Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM (Item Number 11-301343, Lot Number 626750) due to a potential risk of device failure.
The hip implant component could potentially exhibit chatter and fretting corrosion in the inner taper. If this occurs, it could lead to device failure and require surgical intervention. The product was distributed nationwide in the United States.
This is a Class II recall by the FDA. Patients who have received this implant component should contact their surgeon to discuss any concerns related to their hip implant.
The recalled product
- Product
- Arcos Modular Revision Hip System Standard Cone Prox Body, Size C, 80 MM Item Number: 11-301343
- Manufacturer
- Biomet, Inc.
- Category
- Medical Device — Hip Implant
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 : 626750 (01)00880304474499(17)310415(10)626750
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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