Arthrex® AR-9607SRecalls & reported problems
Arthrex, Inc. · PIN SET, MODULAR GLENOID SYSTEM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867311442), received between Mar 15, 2021 and Mar 15, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pulmonary Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THROUGH THE SURGICAL OUTCOME SYSTEM THAT A PULMONARY EMBOLISM RESULTING IN INPATIENT HOSPITALIZATION OCCURRED DURING A SHOULDER ARTHROPLASTY PROCEDURE IN WHICH ARTHREX PRODUCT WAS BEING USED. THE PATIENT WAS TREATED WITH CONCOMITANT MEDICATION. THE FACILITY REPORTED THAT THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND IS RECOVERING.
Patient problems: Pulmonary Embolism
MAUDE report 11484134 ↗
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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.
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