CinchLock CAT02462Recalls & reported problems

Summary

The FDA's MAUDE database contains 124 adverse event reports that list this exact device (DI 07613252633228), received between May 25, 2018 and Jun 19, 2026 — classified as 14 injuries, 110 malfunctions.

The most frequently reported specific device problem is “Fracture” (37 reports).

2 other recalls cover devices cleared under the same FDA submission (K131769); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 124 reports, in the reporter's own words as published by the FDA.

• InjuryJun 19, 2026Material Separation

  IT WAS REPORTED THAT FOR THE INVOLVED CINCHLOCK SS ANCHOR. AFTER ANCHOR INSERTION, WHILE TENSIONING THE TAPE, THE TAPE PHYSICALLY BROKE THROUGH THE SIDE OF THE ANCHOR. THE SUTURE ITSELF REMAINED INTACT, BUT THE ANCHOR FAILED. AFTER THESE FAILURES, THE SURGEON MADE THE DECISION TO ABANDON THE LABRAL REPAIR AND INSTEAD DEBRIDE AND REMOVE THE PATIENT¿S LABRUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25565571 ↗
• MalfunctionMay 11, 2026Fracture; Separation Problem

  IT WAS REPORTED THAT WHEN THE CINCHLOCK ANCHOR WAS DEPLOYED, THE DEPLOYMENT WIRE SNAPPED. AS A RESULT, THE ANCHOR COULD NOT BE SUCCESSFULLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137868 ↗
• MalfunctionMar 6, 2026Material Fragmentation

  IT WAS REPORTED THAT THE IMPLANT BROKE DURING INSERTION. A SPARE DEVICE WAS AVAILABLE. ALL BROKEN PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533628 ↗
• MalfunctionDec 12, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR WAS THREADED NORMALLY AND PLACED IN THE HOLE. WHEN TIGHTENING/ADJUSTING THE THREAD TENSION, THE THREAD WAS TORN OUT OF THE ANCHOR. THE ANCHOR WAS THEREFORE NOT TRIGGERED AND WAS PULLED OUT OF THE HOLE. THE ANCHOR REMAINED IN THE BONE; THE TRIGGER MECHANISM WAS PULLED OUT. FURTHER INFO REPORTED: THE THREAD WAS TORN FROM THE ANCHOR. THIS MEANS THAT EITHER THE PROXIMAL PART OF THE ANCHOR IS BROKEN OR THE THREAD IS TORN. THE THREAD WAS STILL INTACT AND COULD BE USED FOR THE NEXT ANCHOR. WE COULDN'T SEE THE ANCHOR BECAUSE IT WAS EMBEDDED IN THE BONE. BASED ON OUR OBSERVATIONS, I HAVE TO ASSUME THAT THE ANCHOR IS BROKEN. WE DIDN'T SEE THE ANCHOR COME OUT OF THE HOLE. IT IS POSSIBLE THAT PART OF IT WAS DRILLED OUT FOR THE REST OF THE PROCEDURE (PLACEMENT OF ADDITIONAL ANCHORS). THE NEXT STEP WAS TO DRILL A NEW HOLE IN THE BONE TO REFIX THE LABRUM WITH A NEW ANCHOR. ESTIMATED DELAY: 5 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794392 ↗
• MalfunctionOct 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY LABRAL REPAIR, A CINCHLOCK SS ANCHOR WAS USED AND INSERTED INTO THE DRILLED HOLE. AS REPORTED, THE WIRE GOT STUCK IN THE ANCHOR WHEN ANCHOR WAS DEPLOYED. THE SURGEON CUT THE ANCHOR SHORT TO BE FLUSH WITH THE ANCHOR AND REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23367905 ↗
• MalfunctionSep 25, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR FAILED AND PEEK ANCHOR SNAPPED. ANCHOR WAS ABLE TO BE PULLED OUT AND REPLACED WITH ANOTHER CINCHLOCK SUCCESSFULLY. THERE WAS NO KNOWN IMPACT OF THIS FAILED DEVICE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23150431 ↗
• MalfunctionSep 23, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE CINCHLOCK SS ANCHOR WAS DEPLOYED IN THE JOINT SPACE THE WIRE THAT GOES THROUGH THE CENTER OF THE ANCHOR DID NOT DISENGAGE AS NORMAL. THE ENTIRE LENGTH OF THE WIRE WAS LEFT IN THE PATIENT¿S JOINT AT FIRST AND THE INNER PEEK COMPONENT OF THE ANCHOR WAS LOOSE. THE SURGEON HAD TO WORK TO REMOVE THE INNER COMPONENT, AND WIRE TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23128289 ↗
• MalfunctionJul 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE BROKE OFF IN IMPLANT WITH A CINCHLOCK SS ANCHOR. THE WIRE WAS REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22515805 ↗
• MalfunctionJun 6, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CINCHLOCK ANCHOR DEPLOYED WITH A WIRE TAIL REMAINING BEHIND THAT NEED TO BE CLIPPED AND REMOVED. THERE WAS HEIGHTENED BLEEDING DUE REMOVAL OF WIRE. THE WIRE WAS COMPLETELY REMOVED FROM THE PATIENT. NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE HEIGHTENED BLEEDING DURING THE REMOVAL OF WIRE. THERE WERE NO FURTHER ADVERSE PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22161285 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING HIP LABRAL REPAIR, THE CINCHLOCK SS ANCHOR WAS INSERTED AND TENSIONED WITHOUT ISSUE. WHEN THE SURGEON WENT TO LOCK THE ANCHOR AND REMOVE THE INSERTER, THE PULL WIRE REMAINED INSIDE THE ANCHOR EXTENDING OUT THROUGH THE TRANSPORT CANNULA OUTSIDE OF THE JOINT/BODY. THE PULL WIRE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21914485 ↗
• MalfunctionApr 25, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE ANCHOR WAS INSERTED TO THE LASERLINE. UPON TENSIONING, THE SUTURE TAPE BROKE THROUGH THE ANCHOR. AFTER THIS, THE SURGEON PULLED ON THE INSERTER TO REMOVE THE IMPLANT. THIS WAS IDENTIFIED DURING THE PROCEDURE WHEN IT COULD BE SEEN THE NITINOL ROD WAS STILL ATTACHED TO THE ANCHOR. ALL PIECES WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21913685 ↗
• MalfunctionApr 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE HANDLE FOR THE ANCHOR DEPLOYMENT WAS SQUEEZED, THE WIRE THAT PULLS THE DISTAL TIP OF THE ANCHOR INTO THE MAIN BODY OF THE ANCHOR, SNAPPED, AND WAS LEFT IN THE ANCHOR. THE WIRE REMAINED AT SIGNIFICANT LENGTH STILL ATTACHED TO THE ANCHOR. THE SURGEON HAD TO ACT TO REMOVE THE WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911947 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE CINCHLOCK SS ANCHOR WAS DEPLOYED DURING PROCEDURE AND SOME OF THE WIRE BROKE OFF FROM THE ANCHOR AND INSERTER. THE WIRE RUNNING THROUGH THE CINCHLOCK SS IMPLANT BROKE OFF IN THE JOINT SPACE AS THE WIRE WAS NOT COMPLETELY RELEASED FROM THE IMPLANT AS IT NORMALLY IS. THE WIRE WAS SUCCESSFULLY ABLE TO BE REMOVED FROM THE PATIENT AFTER ADDITIONAL EFFORT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21886757 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE HANDLE WAS DEPRESSED, THE PULL WIRE DID NOT COME OUT WITH THE INSERTER AND WAS LEFT STICKING OUT OF THE MIDDLE OF THE ANCHOR ALL THE WAY OUT OF THE PATIENT. HAD TO MANUALLY PULL THE WIRE OUT OF THE ANCHOR. ANCHOR REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21885737 ↗
• MalfunctionApr 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE HANDLE WAS DEPRESSED, THE PULL WIRE DID NOT COME OUT WITH THE INSERTER AND WAS LEFT STICKING OUT OF THE MIDDLE OF THE ANCHOR ALL THE WAY OUT OF THE PATIENT. HAD TO MANUALLY PULL THE WIRE OUT OF THE ANCHOR. ANCHOR REMAINED IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884403 ↗
• MalfunctionApr 17, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE AND HAD TO WAIT 30 MINS FOR REPLACEMENT. PLEASE NOTE THAT THE BROKEN PIECES WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21862249 ↗
• InjuryApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE AND HAD TO WAIT 30 MINS FOR REPLACEMENT. ONE (1) FAULTY ANCHOR WAS UNABLE TO BE REMOVED AND LEFT INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21862202 ↗
• MalfunctionApr 17, 2025Fracture; Material Fragmentation; Fracture; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE AND HAD TO WAIT 30 MINS FOR REPLACEMENT. PLEASE NOTE THAT THE BROKEN PIECES WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21861454 ↗
• MalfunctionApr 17, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE STAYED IN CINCHLOCK SS ANCHOR WHEN DEPLOYED. THE WIRE WAS CUT ALONG WITH THE SUTURE AS LOW AS POSSIBLE TO BE FLUSH WITH THE ANCHOR. THE SURGEON ATTEMPTED TO PULL IT OUT, BUT IT DIDN'T BUDGE SO HE LEFT IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21854151 ↗
• InjuryApr 16, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE DIDN'T REMOVE FROM ANCHOR WHEN DEPLOYED. WIRE WAS VISIBLE IN THE CAMERA VIEW OF OUR SCOPE. MOST OF THE EXPOSED WIRE WAS ABLE TO BE GOTTEN OUT. HOWEVER, BASED ON X-RAY, SOME IS STILL INSIDE THE ANCHOR WITH NO WAY TO REALLY REMOVE IT FROM THERE WITHOUT DRILLING THE ANCHOR OUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21852561 ↗
• MalfunctionApr 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS CUT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810453 ↗
• MalfunctionApr 9, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PULL WIRE REMAINED IN THE ANCHOR. THE PULL WIRE WAS CUT OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21810381 ↗
• InjuryMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING HIP LABRAL REPAIR, THE CINCHLOCK SS ANCHOR WAS INSERTED AND TENSIONED WITHOUT ISSUE. WHEN THE SURGEON WENT TO LOCK THE ANCHOR AND REMOVE THE INSERTER, THE PULL WIRE REMAINED INSIDE THE ANCHOR EXTENDING OUT THROUGH THE TRANSPORT CANNULA OUTSIDE OF THE JOINT/BODY. AS A RESULT, THE PULL WIRE BROKE AND THERE ARE PIECES REMAINING IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21712701 ↗
• MalfunctionMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT PULL WIRE REMAINING IN THE ANCHOR. THE PULL WIRE WAS PULLED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712368 ↗
• InjuryMar 27, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE WIRE WAS NOT ABLE TO BE REMOVED COMPLETELY, AND A PORTION OF THE PULL WIRE REMAINED INSIDE THE ANCHOR AFTER IT WAS FLUSH CUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 21712185 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131769. One submission often covers many models, so check the product and lot details in each record.

• Z-2645-2023 · Aug 23, 2023 · Open, Classified
  Cinchlock SS Knotless Anchor Inserter, Part Number CAT02462
• Z-1634-2016 · Apr 12, 2016 · Terminated
  CinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT0246