Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design History
Biomet is recalling specific lots of the A.L.P.S. Proximal Humerus Plating System 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 indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is procedural (incomplete documentation) rather than a direct physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System, specifically the High Plate Right 7 Hole 140MM (Item Number: 110030407). The recall affects Lot Number 408910. 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 affected units were distributed to the field without having completed design history files or design transfer activities. This procedural deficiency means the devices were released without the full documentation required to verify their design and manufacturing compliance.
The affected devices were 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 and patients who have received this specific lot of the plating system should contact Biomet for further instructions regarding the recall.
The recalled product
- Product
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 7 HOLE 140MM, Item Number: 110030407 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
- Manufacturer
- Biomet
- Hazard
- 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 (1)
- Lot Number: 408910 (01)00887868134876(17)270519(10)408910
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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