Biomet Recalls Acetabular Shells Due to Label Color Code Conflict
Biomet, Inc. is recalling 16 Ranawat/Burnstein Acetabular Shells because the label color code conflicts with the liner size.
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, which corresponds to a moderate severity score. The hazard is a minor labeling error (color code conflict) rather than a structural defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Biomet, Inc. is recalling 16 units of the Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated. The recall is due to a labeling error where the color code on the label conflicts with the liner size; specifically, a liner size of 24 should be indicated by a green color code, but the label displays yellow.
The affected devices are metallic, full-hemisphere acetabular shell components intended for cemented or non-cemented total hip replacement in skeletally mature individuals. The specific units involved are identified by Part 11-106054 and Lot 528310.
The recall covers a nationwide distribution, including California, Indiana, North Carolina, Ohio, and Utah. Healthcare providers and facilities should stop using the affected devices and contact Biomet, Inc. for further instructions.
The recalled product
- Product
- Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of…
- Manufacturer
- Biomet, Inc.
- Hazard
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)
- Part 11-106054 Lot 528310
Distribution
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