The Recall Desk
HighFDA (Devices)·Z-2305-2020·Announced 2020-06-17

Biomet A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw Recalled

Biomet is recalling A.L.P.S. Proximal Humerus Plating System Drill Block Set Screws because they were distributed without completed design history files or design transfer activities.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which indicates a risk of temporary or medically reversible adverse health consequences. The hazard involves a procedural compliance failure (incomplete design history files) rather than a reported injury or specific physical defect like a fracture or contamination.

Plain-English summary

Biomet is recalling the A.L.P.S. Proximal Humerus Plating System Drill Block Set Screw, Item Number 110017551. 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.

The affected lot number is P0217 (01)00887868135026(10)P0217. The quantity involved is 5 OUS. The product was distributed worldwide, including US nationwide distribution in the states of NY, GA, FL, and MO, as well as in Canada, Australia, Chile, China, Japan, Malaysia, and the Netherlands. Healthcare providers should contact Biomet for further instructions regarding the return or replacement of these devices.

The recalled product

Product
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK SET SCREW, Item Number: 110017551 - 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
5

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: P0217 (01)00887868135026(10)P0217

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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