Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling A.L.P.S. Proximal Humerus Plate Templates 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 documentation) 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. Proximal Humerus Plating System Proximal Humerus Plate Templates, Item Number 110025472. 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. The agency has classified this recall as Class II.
The affected units are distributed worldwide, including US nationwide distribution in New York, Georgia, Florida, and Missouri, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. The specific lot numbers involved are 429698, 451853, and 462794. Healthcare providers should contact Biomet for instructions on how to handle the affected devices.
The recalled product
- Product
- A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 140MM Item Number: 110025472 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Hazard
- Affected units
- 78
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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