The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2324-2020·Announced 2020-06-17

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 in the source text, and the hazard is procedural (missing documentation) rather than a direct physical defect causing harm.

Plain-English summary

Biomet is recalling specific units of the A.L.P.S. Proximal Humerus Plating System, High Plate Right 14 Hole 234MM (Item Number: 110030409). The recall involves 2 units (OUS) from Lot Number 356320. These medical devices are 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 is an FDA 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 products 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 facilities should stop using the affected units and contact Biomet for further instructions on the recall process.

The recalled product

Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 14 HOLE 234MM, Item Number: 110030409 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal healing process.
Manufacturer
Biomet
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
2

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: 356320 (01)00887868134890(17)270720(10)356320

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

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.

See all 22 products in this recall →

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