The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2263-2021·Announced 2021-08-18

Biomet Hip Implant Cone Bodies Recalled Due to Fretting Corrosion Risk

Biomet is recalling 22 units of Arcos hip implant cone bodies that may develop inner taper fretting corrosion, potentially causing device failure and requiring 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 device with potential for device failure and surgical intervention, but no reported illnesses or injuries. This is a high-risk product where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM (Item Number: 11-301311). A total of 22 units were distributed nationwide in the United States, with affected lot numbers 678930 and 880200.

The proximal cone bodies in this hip system could potentially develop chatter and fretting corrosion at the inner taper interface. This corrosion may lead to device failure that would require surgical intervention to address.

Surgeons and healthcare facilities that implanted this device should contact Biomet for information on patient monitoring, management options, or device replacement. Patients who have received this implant should contact their healthcare provider if they experience hip pain, instability, or other concerning symptoms.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size A, 60 MM Item Number: 11-301311
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Hip Implant
Hazard
Affected units
22

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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