Biomet Recalls Proximal Humerus Plate Templates Due to Incomplete Design Files
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 specific defect is a documentation issue (incomplete design history files) rather than a direct physical hazard or reported injury, fitting the 'Moderate' criteria for minor labeling/documentation errors.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System Proximal Humerus Plate Template 234MM (Item Number 110025473). 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 a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected units are identified by Lot Numbers 452448 and 462794. The source text indicates a quantity of 48 OUS and distribution worldwide, including the US (specifically NY, GA, FL, MO) and 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 PROXIMAL HUMERUS PLATE TEMPLATE 234MM Item Number: 110025473 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Hazard
- Affected units
- 48
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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