The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2270-2021·Announced 2021-08-18

Biomet Arcos Hip Implant Revision Bodies Recalled for Corrosion Risk

Biomet is recalling specific Arcos hip implant components due to potential fretting corrosion of the inner taper that could lead to device failure and require surgical intervention.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device recall involving risk of device failure requiring surgical intervention. No cases of illness or injury have been reported, but the recall addresses a preventive risk of harm from fretting corrosion in implant components.

Plain-English summary

Biomet, Inc. is recalling specific Arcos Modular Revision Hip System High Offset Cone Prox Body components (Size A, 70 MM) with lot numbers 880380 and 880870. These devices are distributed nationwide in the United States.

The recalled devices could potentially exhibit chatter in the inner taper, which may lead to fretting corrosion and device failure while in use. Device failure could necessitate surgical intervention to restore hip function.

Patients who have received this hip implant component should contact their surgeon to verify whether they received a recalled device using the lot numbers provided. Healthcare providers should check their inventory for the affected lot numbers and take appropriate steps to monitor and manage patients with these devices.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 70 MM Item Number: 11-301331
Manufacturer
Biomet, Inc.
Category
Medical Device — Hip Implant
Hazard

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 →

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