Arthrex® AR-9235Recalls & reported problems

Arthrex, Inc. · PRESSURIZER, PEGGED GLENOID · Class 1

Data updated Oct 16, 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 00888867059467), received between Jun 18, 2024 and Jun 18, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Device Contamination with Chemical or Other Material1

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 18, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
ON 01/10/2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9233 CONSTANT CEMENT AND HUMAN TISSUE STUCK IN GROOVES ON ITEMS DESPITE MULTIPLE RUNS THROUGH SPD.
Patient problems: Insufficient Information
MAUDE report 19559241 ↗

Device details

UDI-DI	`00888867059467`
Brand	Arthrex®
Model	AR-9235
Company	Arthrex, Inc.
Product code	MDM · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
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	Nov 16, 2021

Device type (GMDN): Surgical drill guide, reusable

A manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Other INSTRUMENT, MANUAL, SURGICAL, GENERAL USE devices

Arthrex® AR-13995N
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
430 reports
Arthrex® AR-12990N
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
197 reports
Arthrex® AR-13991N
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
128 reports
Arthrex® AR-8981-08S
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall3 reports
Arthrex® AR-8981-06S
Arthrex, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall1 report
Centurion EB16
Centurion Medical Products Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports
Medline Industries, Inc. DYNJ901391D
Medline Industries, Inc. · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports
HarmonyAIR LAS0042
Steris Corporation · INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
1 recall0 reports

All INSTRUMENT, MANUAL, SURGICAL, GENERAL USE 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page