The Recall Desk
HighFDA (Devices)·Z-2272-2021·Announced 2021-08-18

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

Biomet is recalling hip replacement components that could develop fretting corrosion and fail inside the body, 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 hip implant component with a theoretical risk of failure. No injuries or hospitalizations have been reported. The potential hazard of fretting corrosion leading to device failure and revision surgery presents a significant risk to patient safety, warranting a High severity classification.

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E (Item Number 11-301335, Lot 881130) due to potential device failure.

The affected components could exhibit chatter in the inner taper, leading to fretting corrosion and device failure in vivo. If device failure occurs, patients may require revision surgery.

The recalled components were distributed nationwide in the United States.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 70 MM Item Number: 11-301335
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant / Hip System
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 : 881130 (01)00880304480483(17)310418(10)881130

Distribution

Distributed nationwide across the United States.

Related recalls

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