Arthrex® AR-8954ML-SRecalls & reported problems
Arthrex, Inc. · CALCFX PERCPLT,STD ANTERI PROCESS L · Class 2 · Implant
Data updated Oct 18, 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 00888867055308), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Failure to Advance” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Failure to Advance1
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.
MalfunctionJul 8, 2025Failure to Advance; Failure to Advance
ON 06/11/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-8954ML-S CALCANEAL FRACTURE PERCUTANEOUS PLATE (FROM LOANER ORDER: (B)(4), SET RAR-8950S-02, SERIAL NUMBER: (B)(6) WAS SELECTED FOR USE. HOWEVER, THE SURGEON WAS UNABLE TO ENGAGE ANY LOCKING SCREWS WITH THE PLATE. THE ISSUE COULD NOT BE RESOLVED DESPITE MULTIPLE ATTEMPTS, AND THE PLATE WAS DEEMED UNUSABLE. THE CASE WAS COMPLETED BY OPENING ANOTHER AR-8954ML-S CALCANEAL FRACTURE PERCUTANEOUS PLATE FROM ANOTHER SET, AND IT FUNCTIONED WITHOUT ISSUE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 06/24/2025.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22441673 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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