A.L.P.S.® Proximal Humerus Plating System 110025446Recalls & reported problems

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00887868530784), received between Jun 25, 2025 and Jun 25, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Migration” (1 report).

18 other recalls cover devices cleared under the same FDA submission (K143697); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Migration1

Patient problems

Insufficient Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 25, 2025Migration; Migration
IT WAS REPORTED THAT APPROXIMATELY FOUR (4) MONTHS AFTER A SHOULDER PROCEDURE, THE PLATING SYSTEM MIGRATED FROM ITS INTENDED POSITION AND THE DISTAL PORTION OF THE PLATE MAY HAVE LIFTED. NO REVISION SURGERY IS PLANNED AT THIS TIME. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
Patient problems: Insufficient Information
MAUDE report 22330775 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143697. One submission often covers many models, so check the product and lot details in each record.

Z-2319-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 7 HOLE 140MM, Item Number: 110030307 - Product Usage: Intended for temporary internal fixation and stabilization of osteoto
Z-2317-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE RIGHT 11 HOLE 190MM, Item Number: 110030208 - Product Usage: Intended for temporary internal fixation and stabilization of osteo
Z-2318-2020 · May 14, 2020 · Terminated
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 osteot
Z-2324-2020 · May 14, 2020 · Terminated
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 osteo
Z-2311-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM LOCKING PEG 60MM , Item Number: 110025460 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies
Z-2306-2020 · May 14, 2020 · Terminated
A.L.P.S PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 3.2MM, Item Number: 110017553 - Product Usage: Intended for temporary internal fixation and stabilization of osteot
Z-2312-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM PROXIMAL HUMERUS PLATE TEMPLATE 90MM, Item Number: 110025471 - Product Usage: Intended for temporary internal fixation and stabilization
Z-2320-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 11 HOLE 197MM, Item Number: 110030308 - Product Usage: Intended for temporary internal fixation and stabilization of osteot
Z-2315-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM LOW PLATE LEFT 11 HOLE 190MM, Item Number: 110030108 - Product Usage: Intended for temporary internal fixation and stabilization of osteoto
Z-2305-2020 · May 14, 2020 · Terminated
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 an
Z-2316-2020 · May 14, 2020 · Terminated
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 osteoto
Z-2307-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM DRILL BLOCK GUIDE SLEEVE 2.7MM, Item Number: 110017563 - Product Usage: Intended for temporary internal fixation and stabilization of osteo
Z-2309-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM 3.2MM CALIBRATED DRILL BIT, Item Number: 110017737 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomi
Z-2321-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE LEFT 14 HOLE 234MM, Item Number: 110030309 - Product Usage: Intended for temporary internal fixation and stabilization of osteot
Z-2323-2020 · May 14, 2020 · Terminated
A.L.P.S. PROXIMAL HUMERUS PLATING SYSTEM HIGH PLATE RIGHT 11 HOLE 197MM, Item Number: 110030408 - Product Usage: Intended for temporary internal fixation and stabilization of osteo

…and 3 more.

Device details

UDI-DI	`00887868530784`
Brand	A.L.P.S.® Proximal Humerus Plating System
Model	110025446
Company	Biomet Orthopedics, LLC
Product code	HRS · Plate, fixation, bone
Class	Class 2
FDA submission	K143697
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 30, 2025

Device type (GMDN): Orthopaedic bone screw, non-bioabsorbable, sterile

A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

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All Plate, fixation, bone devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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