The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2269-2021·Announced 2021-08-18

Hip implant component recalled due to potential corrosion and failure risk

Biomet is recalling 11 units of a hip replacement component that could experience inner taper corrosion and failure, potentially requiring surgical intervention. 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: No illnesses or injuries reported in the source. The hazard is described as theoretical ('could potentially exhibit'). However, this is a risk-of-harm product (orthopedic implant) where failure would require surgical intervention, meeting the High-risk criteria for medical devices without reported adverse events.

Plain-English summary

Biomet, Inc. is recalling 11 units of the Arcos Modular Revision Hip System Standard Cone Prox Body (Size E, 70 MM, Lot 880850) distributed nationwide in the United States. The component could potentially exhibit chatter and inner taper fretting corrosion, which may lead to device failure and require surgical intervention.

Patients who received this hip implant component should contact their surgeon if they have questions or concerns about the device. No injuries or illnesses have been reported to date. The recall was initiated due to the potential risk of device failure that could necessitate revision surgery.

The recalled product

Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size E, 70 MM Item Number:11-301325
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
11

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 : 880850 (01)00880304480575(17)310412(10)880850

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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