The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2265-2021·Announced 2021-08-18

Arcos Hip Implant Component Recalled for Potential Device Failure

Biomet recalled 10 units of Arcos hip implant components (lot 934870) nationwide due to potential inner taper corrosion and device failure that may require 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 medical device recall with theoretical risk of device failure requiring surgical intervention, but no reported illnesses or injuries to date. The hazard is based on potential inner taper corrosion and chatter, representing a risk-of-harm scenario without manifested injury.

Plain-English summary

Biomet, Inc. is recalling 10 units of the Arcos Modular Revision Hip System High Offset Cone Prox Body (Size D, 60 MM, Item Number 11-301314, Lot 934870) for nationwide distribution.

The recalled component could potentially develop chatter in the inner taper, leading to fretting corrosion and device failure. If the device fails in the patient's body (in vivo), surgical intervention may be required to address the failure.

Patients who received this hip implant component should contact their healthcare provider if they experience unusual pain, loosening, or instability in the affected hip, and discuss whether they should be evaluated. Healthcare providers should verify whether the product they used matches the recalled lot number.

The recalled product

Product
Arcos Modular Revision Hip System High Offset Cone Prox Body, Size D, 60 MM Item Number: 11-301314
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

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 : 934870 (01)00880304474024(17)310419(10)934870

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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