The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2316-2020·Announced 2020-06-17

Biomet Recalls Proximal Humerus Plating System Due to Incomplete Design Files

Biomet is recalling 16 units 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 corresponds to a moderate severity score. The hazard involves incomplete documentation (design history files) rather than a direct physical defect or reported injury, fitting the criteria for a voluntary precautionary or documentation-related recall.

Plain-English summary

Biomet is recalling 16 units of the A.L.P.S. Proximal Humerus Plating System, Low Plate Left 14 Hole 227MM (Item Number: 110030109). The recall was initiated because the devices were 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 specific lot number is 356240 (01)00887868134784(17)270717(10)356240.

Distribution was 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 instructions on how to handle the recalled devices.

The recalled product

Product
A.L.P.S.¿ PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 14 HOLE 227MM, Item Number: 110030109 - 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
16

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: 356240 (01)00887868134784(17)270717(10)356240

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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