Biomet Polaris 5.5 Button Lock Screw Inserter Recalled for Hardness Defect
Ebi, LLC is recalling 15 units of Biomet Polaris 5.5 Button Lock Screw Inserters because the hardness of broken units was found to be below acceptable limits.
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, and the source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Ebi, LLC is recalling 15 units of Biomet Polaris 5.5 Button Lock Screw Inserters, catalog number 14-500178. The recall involves lot numbers 540199 and 540199-1.
The recall was initiated because the hardness of broken screw insertors was measured and found to be below acceptable limits. The agency has classified this as a Class II recall.
The affected products were distributed nationwide, including in Missouri, Texas, and Indiana. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- Biomet Polaris 5.5 Button Lock Screw Inserter. Catalog number 14-500178
- Manufacturer
- Ebi, Llc
- Hazard
- Affected units
- 15
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)
- Lot Numbers 540199
- 540199-1
Distribution
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