Biomet A.L.P.S. T15 Multi-Directional Locking Screw Recalled for Design History Deficiencies
Biomet is recalling A.L.P.S. T15 Multi-Directional Locking Screws 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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a documentation and process deficiency (incomplete design history files) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet is recalling A.L.P.S. T15 Multi-Directional Locking Screws (3.5mm x 60mm, Item Number 110017960). The recall involves 15 units distributed worldwide, including in the United States, Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
The recall was initiated because the devices were distributed to the field without having completed design history files or design transfer activities. The product is intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
The specific lot number is RM540H (01)00887868132490(17)260623(10)RM540H. Healthcare providers and patients should contact Biomet for further instructions regarding the recall.
The recalled product
- Product
- A.L.P.S. T15 Multi-Directional Locking Screw 3.5mm x 60mm, Item Number: 110017960 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- 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: RM540H (01)00887868132490(17)260623(10)RM540H
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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