Arthrex® AR-2326PSLCRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867289154), received between May 26, 2023 and Feb 2, 2026 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 reports).

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

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 2, 2026Device Dislodged or Dislocated

  ON 2ND FEBRUARY 2026, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2326PSLC, PEEK SWIVELOCK, 3.9X17.9MM, THE ANCHOR PULLED OUT FROM THE PATIENT'S HUMERAL HEAD FOLLOWING ATTEMPTED IMPLANTATION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR PROCEDURE ON 12TH FEBRUARY 2026. THE PROCEDURE WAS COMPLETED AS THEY USED A LARGER ANCHOR AS A SUITABLE ALTERNATIVE (AR-2324PSLC OPENED AND IMPLANTED.)

  Patient problems: Insufficient Information

  MAUDE report 24232756 ↗
• MalfunctionOct 17, 2025Break; Defective Device; Break; Defective Device

  ON 10/09/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2325PSLC PEEK LABRAL SWIVELOCK SUTURE ANCHOR AND AN AR-2326PSLC PEEK SWIVELOCK ANCHOR WERE MISSHAPED AND BROKE UPON INSERTION. NO FURTHER DETAILS WERE PROVIDED. THE ISSUE WAS IDENTIFIED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/10/2025.

  Patient problems: Insufficient Information

  MAUDE report 23328416 ↗
• MalfunctionFeb 25, 2025Mechanical Jam; Mechanical Jam

  ON 02/12/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2326PSLC PEEK SWIVELOCK ANCHOR HAD AN ISSUE WITH THE EYELET NOT RELEASING FROM THE ANCHOR INSERTER DURING A CASE. THE SURGEON ATTEMPTED TO INSERT IT TWICE AND COULD NOT GET THE EYELET TO RELEASE, SO THE SURGEON WENT WITH A DIFFERENT ANCHOR THAT OPERATED SUCCESSFULLY AND COMPLETED THE CASE. THIS WAS DISCOVERED DURING AN ARTHROSCOPIC RCR PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21460290 ↗
• MalfunctionSep 27, 2024Failure to Advance; Failure to Advance

  ON 20 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-2326PSLC PEEK SWIVELOCK, 3.9X17.9MM FAILED TO DEPLOY DURING USE. THIS OCCURRED ON (B)(6) 2024 IN ASCOT HOSPITAL DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20320438 ↗
• MalfunctionSep 26, 2024Failure to Advance; Failure to Advance

  ON 20 SEPTEMBER 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT 2 X AR-2326PSLC PEEK SWIVELOCK, 3.9X17.9MM FAILED TO DEPLOY DURING USE. THIS OCCURRED ON (B)(6) 2024 IN (B)(6) HOSPITAL DURING A ROTATOR CUFF REPAIR. THE CASE WAS COMPLETED SUCCESSFULLY USING A DIFFERENT ANCHOR. THERE WAS CASE INVOLVEMENT.

  Patient problems: Insufficient Information

  MAUDE report 20314744 ↗
• MalfunctionJul 4, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 6/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2326PSLC PEEK SWIVELOCK SUTURE ANCHOR HAD AN ISSUE. DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, THE EYELET OF THE ANCHOR WOULD NOT COME OFF; IT WAS STUCK ON THE DEVICE. NOTHING BROKE INSIDE THE PATIENT, AND THE SURGEON REMOVED EVERYTHING FROM THE PATIENT IN ONE PIECE WITH NO HARM TO THE PATIENT. AN AR-2324PSLC SUTURE ANCHOR, PEEK-SWIVELOCK, WITH LOT NUMBER 15221727, WAS USED TO COMPLETE THE CASE SUCCESSFULLY. THE COMPLAINT DEVICE WAS AVAILABLE FOR RETURN. THERE WAS NO CASE DELAY, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19674250 ↗
• MalfunctionJun 2, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A 3.9 MM PEEK SWIVELOCK WOULD NOT ADVANCE INTO THE PREPARED SOCKET. A 4.0 MM SOCKET WAS DRILLED AND THE ANCHOR WOULD STILL NOT ADVANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19444681 ↗
• MalfunctionJul 6, 2023Break; Break

  ON 6/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2326PSLC PEEK SWIVELOCK EYELET BROKE OFF AND THE SURGEON WAS UNABLE TO THREAD IT BACK ON. ALL THE BROKEN PIECES WERE RETRIEVED AND ANOTHER AR-2326PSLC PEEK SWIVELOCK WAS OPEN. THE SAME THING HAPPENED, THE SWIVELOCK BROKE AT THE PORTION WHERE IT THREADS ON. THE FRAGMENT WAS REMOVED SUCCESSFULLY, AND A THIRD AR-2326PSLC PEEK SWIVELOCK FROM A DIFFERENT LOT NUMBER WAS USED TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17268029 ↗
• MalfunctionMay 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 5/4/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2326PSLC PEEK SWIVELOCK WAS BEING INSERTED IN THE BONE SOCKET WHEN THE SUTURES LET GO OF THE TENDON. THE SURGEON OPTED OUT OF A BICEP TENODESIS REPAIR AND COMPLETED THE CASE AS A TENOTOMY ON (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 17011601 ↗