Biomet A.L.P.S. Proximal Humerus Plating System Drill Bit Recalled
Biomet is recalling A.L.P.S. Proximal Humerus Plating System 3.2mm Calibrated Drill Bits because they were distributed without completed design history files or design transfer activities.
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 procedural (incomplete design documentation) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System 3.2mm Calibrated Drill Bit, Item Number 110017737. The product is intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
The recall was initiated because the product was distributed to the field without having completed design history files or design transfer activities. The recall involves 15 units of the product.
The affected product was distributed worldwide, including nationwide in the United States and in the states of New York, Georgia, Florida, and Missouri. It was also distributed in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The specific lot number is 054380 (01)00887868134845(17)251111(10)054380. Healthcare providers should contact Biomet for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- 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 (1)
- Lot Number: 054380 (01)00887868134845(17)251111(10)054380
Distribution
Part of a larger recall action
This product is one of 22 recalled by Biomet 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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