The Recall Desk
HighFDA (Devices)·Z-2259-2021·Announced 2021-08-18

Arcos Modular Hip Implant Cone Bodies Recalled for Fretting Corrosion

Biomet is recalling specific lots of Arcos Modular Revision Hip System cone bodies due to potential fretting corrosion and device failure that could require surgical intervention.

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 potential for device failure requiring surgical intervention. However, no injuries, illnesses, or actual failures have been reported; the hazard is currently theoretical.

Plain-English summary

Biomet, Inc. is recalling specific lots of the Arcos Modular Revision Hip System Standard Cone Prox Body, Size A (50 MM, Item Number 11-301300). Eighty-eight units were distributed nationwide. The affected lot numbers are 626440, 626450, 626460, 626890, 678370, 678770, 678800, and 695830.

The recalled cone bodies could potentially exhibit chatter and fretting corrosion in the inner taper region, which may result in device failure during use. Device failure could require surgical intervention to address the failed implant.

This is a Class II medical device recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 50 MM Item Number: 11-301300
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic / Hip Implant
Hazard
Affected units
88

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 17 products in this recall →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · fretting corrosion

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