The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0084-2021·Announced 2020-10-14

Biomet ARTHROSIMPLICITY KIT EU Recalled Due to Sterilization Defect

Biomet is recalling ARTHROSIMPLICITY KIT EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

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: The recall is classified as FDA Class II. The hazard involves a medical device that was not properly sterilized, which poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text.

Plain-English summary

Biomet, Inc. is recalling the ARTHROSIMPLICITY KIT EU (Item Number: 24-4055) because the product was not properly aligned with the adequate gamma sterilization group. This alignment error resulted in the product not being properly sterilized.

The recall involves 4 units distributed nationwide and in Canada, Finland, the Netherlands, and the United Kingdom. The affected lot numbers are 894660A, 894660B, 894670B, and 894700B.

Healthcare providers and consumers should stop using the affected products and contact Biomet, Inc. for further instructions or a replacement.

The recalled product

Product
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Instrument
Hazard
Affected units
4

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: 894660A 894660B 894670B 894700B

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 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 4 products in this recall →

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