Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History
Biomet is recalling A.L.P.S. Proximal Humerus Plating System units 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 indicates a documentation and process failure (incomplete design history files) rather than a direct physical defect or reported injury, aligning with the Moderate severity criteria for minor labeling/documentation issues.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System, specifically the Low Plate Left 11 Hole 190MM (Item Number: 110030108). 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 include all lots expiring prior to December 31, 2026. The total quantity involved is 1 US and 1 OUS unit.
Distribution was 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 and patients should contact Biomet for further instructions regarding the recall.
The recalled product
- Product
- A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
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 (2)
- Lot Number: All lots expiring prior to December 31
- 2026
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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