The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0083-2021·Announced 2020-10-14

Biomet ONPOINT SCOPE PROCEDURE KIT-EU Recalled for Sterilization Defect

Biomet, Inc. is recalling ONPOINT SCOPE PROCEDURE 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 improper sterilization of a medical device, which presents a risk of harm (infection) but the source text does not report any specific illnesses or injuries, fitting the criteria for a high-risk product where injury has not yet been reported.

Plain-English summary

Biomet, Inc. is recalling the ONPOINT SCOPE PROCEDURE KIT-EU (Item Number: 24-3055) due to a sterilization defect. The recall is being conducted because the product was not properly aligned with the adequate gamma sterilization group, which resulted in the product not being properly sterilized.

The recall affects 33 units distributed in the United States and 269 units distributed outside the United States. The affected products were distributed nationwide in the US and in Canada, Finland, the Netherlands, and the United Kingdom. The recall covers a specific list of lot numbers, including 866270A, 887060B, and 919100B, among others.

Consumers and healthcare providers should stop using the affected products and contact Biomet, Inc. for further instructions or a replacement. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The recalled product

Product
Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Kits
Hazard

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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