The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2266-2021·Announced 2021-08-18

Hip Implant Component Failure Risk From Inner Taper Fretting Corrosion

Biomet's Arcos hip implant replacement components may develop inner taper fretting corrosion, leading to device failure requiring surgical intervention. Seven units nationwide are affected.

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 of an orthopedic hip implant component with a structural defect (inner taper fretting corrosion) that could result in device failure requiring surgical intervention. No reported deaths, hospitalizations, or injuries are documented in the source.

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System High Offset Cone Prox Body (Size E, 60 MM, Item Number 11-301315) due to a defect in the inner taper component. The affected lot is 626180.

The inner taper of these hip implant components may develop fretting corrosion, which can lead to device failure and chatter. If device failure occurs, patients may require additional surgical intervention to revise or replace the implant.

Seven units of this product were distributed nationwide in the United States. The product is a component of hip replacement systems used in orthopedic surgery.

Patients who have received this implant component should contact their healthcare provider or surgeon. Physicians should be aware of the potential for inner taper degradation in devices from the affected lot and consider appropriate follow-up care and monitoring.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size E, 60 MM Item Number: 11-301315
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant / Hip Replacement
Hazard
Affected units
7

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Numbers/UDI : 626180 (01)00880304480551(17)310414(10)626180

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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