The Recall Desk
HighFDA (Devices)·Z-2271-2021·Announced 2021-08-18

Biomet Hip Replacement Component Recalled Over Corrosion and Device Failure Risk

Biomet is recalling Arcos Modular Revision Hip System components that may develop fretting corrosion in the inner taper, risking device failure and the need for revision surgery. Affected patients should contact their healthcare provider.

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: FDA Class II device recall with no reported injuries or hospitalizations. The product presents a risk of fretting corrosion and device failure that could require surgical intervention, meeting the rubric criteria for High severity (risk-of-harm product with no actual reported injury).

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body (Size C, 70 MM, Item Number 11-301333) due to the potential for fretting corrosion and device failure. The inner taper of the component may develop corrosion that could lead to device failure and require surgical intervention to replace the component.

Twelve units of this specific product were distributed nationwide in the United States. The affected lot number is 696800, identified by the UDI (01)00880304474260(17)310504(10)696800.

Patients who have received this hip system component should contact their healthcare provider to discuss whether they are affected by this recall and to determine appropriate follow-up care. No serious injuries or deaths have been reported to date, but surgical intervention may be necessary if device failure occurs.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size C, 70 MM Item Number: 11-301333
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Hip Replacement
Hazard
  • fretting-corrosion
  • device-failure

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 : 696800 (01)00880304474260(17)310504(10)696800

Distribution

Distributed nationwide across the United States.

Related recalls

Same category