Arthrex® AR-1630Recalls & reported problems

Arthrex, Inc. · LAT DECUBITUS SHOULDR TRACN DEV · Class 1

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867020368), received between Apr 23, 2024 and Jun 19, 2025 — classified as 3 malfunctions.

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

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Defective Device1
Naturally Worn1
Positioning Failure1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Insufficient Information1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 19, 2025Positioning Failure; Positioning Failure
ON 05/28/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1630 LAT DECUBITUS SHOULDER DEVICE MECHANISM THAT ROTATES DID NOT ENGAGE AND WAS ROTATING FREELY. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22292825 ↗
MalfunctionMay 15, 2024Defective Device; Defective Device
IT WAS REPORTED THE CORD ON THE AR-1630 IS NOT WORKING.
Patient problems: Insufficient Information
MAUDE report 19323330 ↗
MalfunctionApr 23, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE SHEATH COVERING THE CABLES HAS COME APART.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19164083 ↗

Device details

UDI-DI	`00888867020368`
Brand	Arthrex®
Model	AR-1630
Company	Arthrex, Inc.
Product code	KQZ · COMPONENT, TRACTION, NON-INVASIVE
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jul 20, 2021

Device type (GMDN): Arm procedure positioner, reusable

A preformed device designed to support and stabilize a patient's arm in a desired position during a medical procedure [e.g., orthopaedic surgery, anaesthesia administration, blood donation, intravenous (IV) infusion, physical therapy massage]. Also known as an arm posturing device or armboard, it is typically constructed as an elongated, curved, cushioned surface, and is typically attached or fixed onto a side rail, operation/examination table, blood donor couch, or a chair, and has adjustable height, tilt, rotation, and lock positioning capabilities. This is a reusable device.

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All COMPONENT, TRACTION, NON-INVASIVE 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 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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