The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2318-2020·Announced 2020-06-17

Biomet A.L.P.S. Proximal Humerus Plating System Recalled for Design Documentation Deficiencies

Biomet is recalling A.L.P.S. Proximal Humerus Plating System units 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 where the probability of serious adverse health consequences is remote.

Plain-English summary

Biomet is recalling specific units of the A.L.P.S. Proximal Humerus Plating System, specifically the Low Plate Right 14 Hole 227MM (Item Number: 110030209). The recall involves one unit in the United States and one unit outside the United States. 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 units were distributed worldwide, including nationwide in the United States and in specific states such as New York, Georgia, Florida, and Missouri. International distribution included Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers and patients should contact Biomet for further information regarding the recall and potential replacement or remediation options.

The recalled product

Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 14 HOLE 227MM, Item Number: 110030209 - 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

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: 356280 (01)00887868134838(17)270716(10)356280
  • RM256H (01)00887868134838(17)260304(10)RM256H

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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