Arthrex® AR-2324KBCCTRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867351127), received between Sep 17, 2020 and Dec 2, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Break; Break

  ON 11/12/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT THE EYELET OF AN AR-2324KBCCT KNOTLESS BIOCOMPOSITE SWIVELOCK ANCHOR FRACTURED AND SNAPPED IN HALF WHILE LOADING TWO SUTURETAPE SUTURES. THE ANCHOR WAS NOT OVERLOADED WITH SUTURE AND WAS LOADED CORRECTLY USING THE MEGALOADER. AS A RESULT, A NEW ANCHOR WAS OPENED AND USED. THIS ISSUE WAS IDENTIFIED DURING A ROTATOR CUFF REPAIR PROCEDURE (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/17/2025: THIS ISSUE OCCURRED DURING PREPARATION. ALL DETACHED PIECES WERE ACCOUNTED FOR. THE CASE WAS COMPLETED WITH A REPLACEMENT AR-2324KBCCT KNOTLESS BIOCOMPOSITE SWIVELOCK ANCHOR. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS WERE REPORTED FOR THIS EVENT. NO PHOTOS WERE TAKEN OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694979 ↗
• MalfunctionMay 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED ON 05/02/2025: THIS OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED USING ONE 2.6 RC FIBERTAK FOR THE MEDIAL ROW AND AR-2324KBCCT FOR THE LATERAL ROW, AND BEFORE INSERTION, THE TAPE WAS REMOVED FROM THE EYELET TO ALLOW THE FIBERTAK SUTURE TO PASS THROUGH INSTEAD. THERE WAS A CASE DELAY DUE TO THE NEED TO RETRIEVE THE EYELET AND ANCHOR ARTHROSCOPICALLY AND PREPARE FOR A NEW ANCHOR. BONE QUALITY WAS DECENT, AND THE FIBERTAK INSERTION PROCEEDED WITHOUT ISSUES. THE SILVER PUNCH, AR-1927PB, WAS USED TO CREATE THE PILOT HOLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21953060 ↗
• MalfunctionFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2324KBCCT SWIVELOCK ANCHORS WERE PULLED OUT OF THE BONE WHEN ATTEMPTING TO TENSION THE KNOTLESS MECHANISM IN A MEDIAL ROW FOR A DOUBLE PULLEY RIPSTOP WITH ROTATOR CUFF REPAIR. THE ANCHORS WERE REMOVED AND NO PIECES BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758684 ↗
• MalfunctionFeb 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 2/2/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-2324KBCCT SWIVELOCK ANCHORS WERE PULLED OUT OF THE BONE WHEN ATTEMPTING TO TENSION THE KNOTLESS MECHANISM IN A MEDIAL ROW FOR A DOUBLE PULLEY RIPSTOP WITH ROTATOR CUFF REPAIR. THE ANCHORS WERE REMOVED AND NO PIECES BROKE INSIDE THE PATIENT. THE CASE WAS COMPLETED WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758561 ↗
• MalfunctionOct 6, 2023Break; Break

  ON 9/7/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2324KBCCT KNOTLESS BIOCOMPOSITE SWIVELOCK EYELET BROKE COMPLETELY DURING INSERTION, RELEASING THE FIBERTAPE LOOP. WHEN THE SURGEON OPENED THE PACKAGE, IT WAS NOTICED THAT THE EYELET OF THE SWIVELOCK LOOKED DIFFERENT; IT WAS SOMEHOW DEFECTIVE AND APPEARED TO HAVE A CRACK WITH THE FIBERTAPE LOOP PARTIALLY LODGED IN IT. THE SURGEON ATTEMPTED TO USE THE SWIVELOCK ANYWAY, IN WHICH THE EYELET BROKE. EVERYTHING WAS REMOVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-2324KBCCT KNOTLESS BIOCOMPOSITE SWIVELOCK FROM THE SAME LOT NUMBER. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 9/7/2023: THE SURGEON REMOVED ALL THE BROKEN FRAGMENTS. THE CASE WAS ONLY DELAYED TWENTY TO THIRTY SECONDS AND ADDITIONAL ANESTHESIA WAS NOT NECESSARY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17890289 ↗
• MalfunctionSep 21, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA E-MAIL THAT WHEN THE SURGEON INSERTED THE AR-2324KBCCT SWIVELOCK ANCHOR INTO THE PATIENT, THE SCREW BROKE MID SHAFT. THE SALES REP EXPLAINED THE PATIENT HAD SOFT BONE. THE FRAGMENT WAS REMOVED AND THE CASE WAS COMPLETED BY USING A NEW AR-2324KBCCT.

  Patient problems: Insufficient Information

  MAUDE report 12507938 ↗
• InjurySep 17, 2020Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE SURGEON EXPERIENCED THE FOLLOWING ISSUES WITH ARTHREX DEVICES, WHEN INSERTING AN AR-2324KBCCT (LOT 10679428) THE SWIVELOCK WAS INSERTED AND UPON REMOVAL OF THE DRIVER, THE PORTION OF THE EYELET THAT CONTAINS THE KNOTLESS MECHANISM REMAINED IN THE CANNULATION OF THE DRIVER. WHEN INSERTING AN AR-2324KBCCTT (LOT 10941879) UPON FINAL TENSIONING OF THE KNOTLESS MECHANISM THE PORTION OF THE EYELET BROKE COMING UP THROUGH THE SCREW, RESULTING IN CUTTING OF THE SUTURE AND REMOVING THE PEEK PORTION OF THE EYELET. THE DISTAL END OF THE EYELET THAT HAS THE FIBERTAPES THROUGH THEM AND THE SCREWS THEMSELVES STAYED IN THE PATIENT FROM EACH ANCHOR. AN AR-1922P GREEN PUNCH HAD BEEN USED TO PREP THE BONE FOR INSERTION. BONE QUALITY OF THE PATIENT WAS REPORTED TO BE GOOD. THE REPORTER STATES THE PATIENT WAS NOT HARMED IN ANY WAY AND THE SPEEDBRIDGE WAS COMPLETED PER TECHNIQUE GUIDE WITH TWO 5.5MM SWIVELOCKS LATERALLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10546269 ↗