The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2273-2021·Announced 2021-08-18

Biomet Hip Implant System Recalled Due to Potential Fretting Corrosion

Biomet is recalling the Arcos Modular Revision Hip System component due to potential inner taper fretting corrosion that could lead to device failure requiring surgery. No injuries have been reported.

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: This is a Class II FDA recall without reported illnesses or injuries. The hazard is theoretical—the device could potentially fail—requiring surgical intervention, but no actual failures or injuries are documented in the source text, placing it at most at score 3 per the rubric.

Plain-English summary

Biomet, Inc. is recalling the Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM (Item Number: 11-301342). The recall affects 12 units distributed nationwide in the United States. The affected lot number is 391390.

The device could potentially exhibit chatter in the inner taper, leading to fretting corrosion and device failure. If device failure occurs, patients may require surgical intervention to address the issue.

Patients who have received this implant should consult their healthcare provider or surgeon. Biomet and the FDA are working to notify affected patients and healthcare providers about this recall.

The recalled product

Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size B, 80 MM Item Number: 11-301342
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
12

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 : 391390 (01)00880304474208(17)310323(10)391390

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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