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Arthrex® AR-9228AGRecalls & reported problems

Arthrex, Inc. · AVL PRIMARY REAMER, MODULAR, SMALL · 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 00888867350434), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (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.

Most reported problems

Device problems

  • Naturally Worn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionAug 9, 2023Naturally Worn; Naturally Worn

    ON 07/11/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-9228AG AUGMENTED GLENOID PRIMARY REAMER IS WORN. THIS WAS DISCOVERED DURING A CASE, WITH NO PATIENT EFFECT REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17486592 ↗

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Sources and updates

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