Biomet Recalls Acetabular Shell Components Due to Packaging Mix-Up
Biomet is recalling specific acetabular shell components for hip prostheses due to a packaging mix-up between two different product lots.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging mix-up, which fits the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling the Ringloc+ Acetabular Shell Finned 52 mm (Lot 427840) and the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600). These are components used in hip prostheses. The recall was initiated following a mix-up in packaging between the two products.
The affected units were distributed in the states of Virginia and Texas, as well as in Japan. A total of 17 units are involved in this recall.
Healthcare providers and patients should check their inventory and records for these specific lot numbers. If these components are found, they should be removed from use and returned to Biomet, Inc. according to the company's instructions.
The recalled product
- Product
- Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
- Manufacturer
- Biomet, Inc.
- Affected units
- 17
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)
- Catalog Number: 16-104152 Lot Number Identification: 427840
Distribution
Part of a larger recall action
This product is one of 2 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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