The Recall Desk
SevereFDA (Devices)·Z-0082-2021·Announced 2020-10-14

Biomet OnPoint Scope Procedure Kit Recalled for Sterilization Defect

Biomet is recalling OnPoint Scope Procedure Kits because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

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 significant risk of infection or serious injury to patients, meeting the criteria for a Severe rating.

Plain-English summary

Biomet, Inc. is recalling 80 units of the Biomet OnPoint SCOPE PROCEDURE KIT (Item Number: 24-3050). The recall involves specific lot numbers distributed nationwide and in Canada, Finland, the Netherlands, and the United Kingdom.

The recall is being conducted because the product was not properly aligned with the adequate gamma sterilization group. This alignment error resulted in the product not being properly sterilized.

Healthcare providers and consumers who have these specific kits should stop using them and contact Biomet, Inc. for instructions on return or replacement.

The recalled product

Product
Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
Manufacturer
Biomet, Inc.
Category
Medical Device — Surgical Kits
Hazard
Affected units
80

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 →

Related recalls

Same manufacturer · Biomet, Inc.

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Same hazard · infection

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