The Recall Desk
HighFDA (Devices)·Z-2274-2021·Announced 2021-08-18

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.

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 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
Hazard
  • device-failure
  • fretting-corrosion
  • chatter

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.

Related recalls

Same category