Biomet Recalls A.L.P.S. Proximal Humerus Plating System for Design Documentation Issues
Biomet is recalling A.L.P.S. Proximal Humerus Plating System plates 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, which typically corresponds to a Moderate severity score (2) when the hazard is procedural (documentation/design transfer) rather than a direct physical defect causing injury, and no illnesses or injuries are reported in the source text.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System High Plate Left 14 Hole 234MM (Item Number: 110030309). 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 recall affects all lots expiring prior to December 31, 2026. The product was distributed worldwide, including in the United States (specifically NY, GA, FL, and MO) and in 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 HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Affected units
- 1
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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