Arthrex® AR-2324KPCTTRecalls & reported problems
Arthrex, Inc. · 4.75mm PEEK KNOTLESS SWIVELOCK w/ TAPE · 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 00888867351158), received between Sep 13, 2024 and Sep 13, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Break” (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
- Break1
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.
MalfunctionSep 13, 2024Break; Break
IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KPCTT PEEK KNOTLESS SWIVELOCK EYELET ATTACHED TO THE KNOTLESS MECHANISM, PULLED OUT THROUGH THE CANNULATION OF THE SCREW. THE PIECE WAS FOUND FLOATING IN THE JOINT AND WAS ABLE TO BE RETRIEVED IN FULL. NO BROKEN PIECES REMAINED IN THE PATIENT. THE ANCHOR BODY ITSELF STAYED IN PLACE. NO KNOWN PATIENT HARM, NO DELAY, AND NO BACKUP DEVICE NEEDED. THE CASE WAS COMPLETED WITHOUT DOING THE KNOTLESS CONSTRUCT. ALTHOUGH, BEFORE THE EYELET HAD BROKEN OFF, THE SURGEON HAD ALREADY DECIDED NOT TO DO THE KNOTLESS CONSTRUCT. THIS WAS DISCOVERED DURING A ROUTINE RCR PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20215301 ↗
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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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