The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2308-2020·Announced 2020-06-17

Biomet A.L.P.S. Cortical Screw Recalled for Incomplete Design History

Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws 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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific issue is a documentation and process failure (incomplete design history files) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Biomet is recalling A.L.P.S. T15 Low Profile Cortical Screws (3.5mm x 28mm, Item Number: 110017628) due to a quality control issue. The recall is being conducted 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 involved is J3835075. The quantity recalled is 15 OUS (Outer Units).

The product was distributed worldwide, including US nationwide distribution in the states of New York, Georgia, Florida, and Missouri, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers and patients should contact Biomet for further instructions regarding the recall.

The recalled product

Product
A.L.P.S. T15 LOW PROFILE CORTICAL SCREW 3.5mm x 28mm, Item Number: 110017628 - 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
15

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: J3835075 (01)00887868131769(17)260722(10)J3835075

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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