The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2267-2021·Announced 2021-08-18

Biomet Arcos Hip Implant Component Recalled for Potential Fretting Corrosion

Biomet is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body components due to potential fretting corrosion at the inner taper joint that could cause device failure and require revision surgery.

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 risk-of-harm orthopedic implant with a specific, material hazard (fretting corrosion potentially causing device failure requiring surgical intervention). The source does not report confirmed injuries, fitting the rubric criterion for Score 3: risk-of-harm products where injury has not been reported.

Plain-English summary

Biomet, Inc. is recalling 11 units of Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM (Item Number 11-301321, Lot 881730) due to potential fretting corrosion at the inner taper connection. The metal components could experience wear caused by movement between surfaces under stress, potentially leading to device failure within the body.

If device failure occurs, the affected patient may require revision surgery to remove and replace the implant. The recalled devices were distributed nationwide throughout the United States.

Patients with this implant component should contact their orthopedic surgeon to determine whether they may be affected and discuss appropriate monitoring or follow-up care. Healthcare providers can identify affected patients using the provided lot number and device identification information.

The recalled product

Product
Arcos Modular Revision Hip System Standard Cone Prox Body, Size A, 70 MM Item Number: 11-301321
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 : 881730 (01)00880304474314(17)310324(10)881730

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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