Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design History Deficiencies
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, which typically corresponds to a Moderate severity score (2) when no specific injuries or illnesses are reported and the hazard is procedural (incomplete documentation) rather than a direct physical defect causing harm.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System, specifically the High Plate Left 11 Hole 197MM (Item Number: 110030308). 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, or where the probability of serious adverse health consequences is remote.
The affected lot number is 408880. The product was distributed worldwide, including US nationwide distribution in New York, Georgia, Florida, and Missouri, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers and facilities 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 11 HOLE 197MM, Item Number: 110030308 - 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 (1)
- Lot Number: 408880 (01)00887868134937(17)270517(10)408880
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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