The Recall Desk
HighFDA (Devices)·Z-2275-2021·Announced 2021-08-18

Hip Prosthetic Component Recalled Due to Potential Fretting Corrosion and Device Failure

Biomet is recalling Arcos hip prosthetic components that may develop corrosion and fail, potentially requiring 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 an FDA Class II recall of a high-consequence orthopedic implant with potential for device failure requiring surgical intervention, but no illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported score as High (3).

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM (Item Number 11-301354, Lot 880960). The recalled components may exhibit chatter in the inner taper, leading to fretting corrosion and potential device failure while in use.

If a prosthetic component fails, surgical intervention would be required to remove and replace the device. Patients who received this component should contact their surgeon or healthcare provider to discuss whether any action is needed.

Healthcare providers with patients who received this component should review the recall details and contact Biomet regarding this issue.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 80 MM Item Number: 11-301354
Manufacturer
Biomet, Inc.
Category
Medical Device — Hip Prosthetic
Hazard
  • fretting-corrosion
  • device-failure
  • 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 : 880960 (01)00880304474307(17)310504(10)880960

Distribution

Distributed nationwide across the United States.

Related recalls

Same category