Biomet Vision RingLoc Hip Prosthesis Recalled for Missing Screw Hole Plugs
Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm hip prosthesis because they were assembled without screw hole plugs.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The defect involves missing components (screw hole plugs) in a medical device, which presents a potential risk but does not meet the criteria for Severe (Class II with hospitalization) or High (high-risk pathogens/allergens). It is not a cosmetic or documentation-only issue, placing it in the Moderate category.
Plain-English summary
Biomet, Inc. is recalling five units of the Vision RingLoc Shell 50 mm Size 23 hip joint replacement prosthesis. The recall is due to a manufacturing defect where the devices were assembled without screw hole plugs.
The affected units are identified by Part Number 135250 and Lot Number 946410. These specific devices were distributed in Canada and Japan.
Consumers and healthcare providers who have these specific units should contact Biomet, Inc. for instructions on how to proceed. The source text does not specify a particular action for end-users beyond the recall notification.
The recalled product
- Product
- Vision RingLoc Shell 50 mm Size 23. Hip joint replacement prosthesis.
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 5
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 (2)
- Part Number:135250
- Lot Number:946410
Distribution
Distribution scope not specified by the agency.
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