Arthrex® AR-2323PSLC-2Recalls & reported problems
Arthrex, Inc. · DBL LOADED 5.5MM PEEK SWVLK · 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 00888867251229), received between Jun 14, 2024 and Jun 14, 2024 — 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
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.
MalfunctionJun 14, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ON 11/15/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2323PSLC-2 SWIVELOCK EYELET SUTURE BROKE BEFORE THE ANCHOR COULD BE INSERTED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(4) 2021. AFTER RECEIVING ADDITIONAL INFORMATION ON 11/16/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT DURING A RCR PROCEDURE, WHEN SURGEON ATTEMPTED TO TIGHTEN THE SUTURETAPES IN THE EYELET, IT BROKE. ANOTHER AR-2323PSLC-2 SWIVELOCK FROM A DIFFERENT LOT WAS USED TO COMPLETE CASE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19537860 ↗
Other Fastener, fixation, biodegradable, soft tissue devices
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- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 reports
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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