The Recall Desk
HighFDA (Devices)·Z-2262-2021·Announced 2021-08-18

Hip Replacement Component Recalled for Potential Device Failure Risk

Biomet is recalling 81 units of a hip replacement component due to potential device failure that could require additional surgery. The affected device is the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A.

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 a risk-of-harm medical device recall where device failure could necessitate surgical intervention. Although no injuries or illnesses have been reported and the hazard is described as potential rather than confirmed, the seriousness of requiring revision surgery places this at High severity.

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A (50 MM), Item Number 11-301310. A total of 81 units with the affected lot numbers have been distributed nationwide in the United States.

The device could potentially exhibit chatter in the inner taper, which may lead to fretting corrosion and device failure inside the body. If this occurs, patients may require additional surgical intervention to revise or replace the component.

Healthcare providers should identify patients who received this device using the lot numbers and UDI codes listed in the recall notice. Patients should contact their healthcare provider if they have questions about whether they received an affected device.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 50 MM Item Number: 11-301310
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Hip Replacement
Hazard
  • device-failure
  • fretting-corrosion
  • surgical-intervention-required

Distribution

Distributed nationwide across the United States.

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