Arthrex® AR-9219Recalls & reported problems
Arthrex, Inc. · KEEL GLENOID TRIAL, LARGE · 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 00888867059153), received between Mar 13, 2025 and Mar 13, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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
Most reported problems
Device problems
- Material Split, Cut or Torn1
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.
MalfunctionMar 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn
ON 02/25/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-9219 LARGE KEEL GLENOID TRIAL WAS CUT IN THE CENTER, AND SPD IS DEEMING IT PART UNUSABLE MOVING FORWARD. THE CASE CARRIED ON AND WAS COMPLETED SUCCESSFULLY. INSTRUMENTS WILL BE SENT BACK FOR EVALUATION. THESE ARE NOT SINGLE USE DEVICES. INSTRUMENTS ARE CONSIGNED INVENTORY.
Patient problems: Insufficient Information
MAUDE report 21594645 ↗
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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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