The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0670-2022·Announced 2022-03-02

Hip implant revision system recalled due to inadequate coating adhesion

Biomet is recalling 19 units of the Arcos Modular Revision Hip System because an incorrect rework process may have weakened the coating's adhesion strength, posing a potential implant failure risk.

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 an FDA Class II medical device recall involving a structural coating defect on an orthopedic implant. The source text reports no illnesses or injuries, only internal testing findings of insufficient coating adhesion strength. Per the rubric, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a score of 3.

Plain-English summary

Biomet, Inc. is recalling 19 units of the Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma, Size A, 60 MM (Item Number 11-301301). The affected units were distributed worldwide, including to the United States, Canada, Ecuador, and the Netherlands.

The recalled units underwent an incorrect rework operation on the porous plasma sprayed coating. Internal testing indicated that the coating may not have sufficient adhesion strength. The defect affects all lots that were porous plasma coated or recoated at an external vendor and then reworked through Biomet's internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products originally coated at a vendor.

Patients with the affected implants (Lot Numbers 853650 or 853810) should contact their healthcare provider or Biomet for further information. Healthcare facilities should identify affected units using the provided lot numbers and UDI codes and contact Biomet for guidance on replacement or removal.

The recalled product

Product
Arcos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma,Size A, 60 MM Item Number: 11-301301
Manufacturer
Biomet, Inc.
Category
Medical Device — Orthopedic Joint Implant
Hazard
Affected units
19

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 (3)

  • Lot Number: 853650
  • 853810 UDI: (01)00880304468030(17) 290122(10)853650
  • (01)00880304468030(17) 290211(10)853810

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

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