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.
What this means for you
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 sur
- 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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