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.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- 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.
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