Arthrex® AR-8941PLSRecalls & reported problems
Arthrex, Inc. · PLANTAR LAPIDUS PLATE, SHORT LEFT · Class 2 · Implant
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 00888867212374), received between Feb 25, 2025 and Feb 25, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Positioning Failure” (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
- Positioning Failure1
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.
MalfunctionFeb 25, 2025Positioning Failure; Positioning Failure
ON 02/11/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN PLANTAR LAPIDUS SHORT PLATE WAS NOT ALLOWING SCREW TO LOCK IN. THIS OCCURRED DURING A LAPIDUS ARTHRODESIS ON (B)(6) 2025, WHEN THE AR-8935L-14 AND AN AR-8935L-18 SCREWS WERE NOT LOCKING INTO THE PLATE. EVERYTHING WAS REMOVED FROM THE PATIENT AND THEY PROCEEDED TO USE A NEW PLATE THAT WORKED. THE AR-8935L-18 SCREW WORKED WITH THE NEW PLATE; THE AR-8935L-14 WAS NOT USED.
Patient problems: Insufficient Information
MAUDE report 21458899 ↗
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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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