Biomet Recalls A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve
Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeves because they were distributed without completed design history files or design transfer activities.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is procedural (incomplete documentation) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System Drill Block Guide Sleeve 2.7MM, Item Number 110017563. 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 devices were distributed to the field without having completed design history files or design transfer activities. This is an FDA Class II recall.
The affected lot number is 3287A (01)00887868135071(10)3287A. The quantity involved is 3 OUS. The product was distributed worldwide, including US nationwide distribution in the states of NY, GA, FL, and MO, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers should contact Biomet for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Hazard
- Affected units
- 3
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: 3287A (01)00887868135071(10)3287A
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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