Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System because units 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 does not report any illnesses, injuries, or hospitalizations. The hazard is procedural (incomplete documentation) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet is recalling the A.L.P.S. Proximal Humerus Plating System, specifically the High Plate Right 11 Hole 197MM (Item Number 110030408). The recall was initiated because the product was distributed to the field without having completed design history files or design transfer activities.
The affected product is intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process. The recall includes units with Lot Number 408920. The product was distributed worldwide, including nationwide in the United States and in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands.
Healthcare providers and patients should contact Biomet for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - 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: 408920 (01)00887868134883(17)270627(10)408920
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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