The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2264-2021·Announced 2021-08-18

Hip Implant Component Recalled for Fretting Corrosion Risk

Biomet is recalling 33 units of the Arcos Modular Revision Hip System due to potential inner taper fretting corrosion 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 a risk-of-harm product (hip implant) where device failure is a potential outcome. The source describes the hazard as theoretical ("could potentially exhibit") with no reported illnesses or injuries, meeting the criterion for Score 3.

Plain-English summary

Biomet, Inc. is recalling 33 units of the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM (Item Number 11-301312) distributed nationwide in the United States.

The recalled components may exhibit fretting corrosion in the inner taper, which could potentially lead to device failure requiring surgical intervention to address.

Affected units are identified by lot numbers 678950, 880250, and 880790. Patients who have received one of these implants should contact their healthcare provider or Biomet immediately.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size B, 60 MM Item Number: 11-301312
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
33

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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