Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design History
Biomet is recalling 78 units of A.L.P.S. Proximal Humerus Plate Templates 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. The hazard is a documentation and process failure (incomplete design history files) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet is recalling 78 units of the A.L.P.S. Proximal Humerus Plating System Proximal Humerus Plate Template 90MM (Item Number: 110025471). 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 affected units are identified by Lot Numbers 429698 and 452448.
The recalled products were distributed worldwide, including in the United States (specifically New York, Georgia, Florida, and Missouri) and in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- 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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