Arthrex® AR-6068-25LRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867247505), received between Dec 21, 2021 and Mar 20, 2026 — classified as 1 injury, 26 malfunctions.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (10 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURE COULD NOT BE PULLED THROUGH PROPERLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649890 ↗
• MalfunctionMar 20, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURE COULD NOT BE PULLED THROUGH PROPERLY. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649887 ↗
• MalfunctionAug 29, 2025Break; Break

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-6068-25L, 25°, CURVE, LEFT QUICKPASS¿ LASSO, LOW PROFILE TIP, ITS TIP BROKE INTRAOPERATIVELY. THIS WAS DETECTED DURING A QUADS ACL WITH RAMP REPAIR PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 22924741 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE HOOK BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637943 ↗
• MalfunctionJul 28, 2025Break; Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE HOOK BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22637942 ↗
• MalfunctionMar 17, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SURGERY THE ROPE AND WHEEL BECAME STUCK AND THE LASSO BECAME LOCKED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21618885 ↗
• MalfunctionJan 20, 2025Positioning Failure; Positioning Problem; Positioning Failure; Positioning Problem

  IT WAS REPORTED THAT DURING A KNEE SURGERY A MALFUNCTION AT THE DEVICE APPEARS, THE WIRE DOES NOT WIND UP. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21190483 ↗
• MalfunctionJul 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SURGEON NOTICED THAT DURING USE AND THREAD INSERTION THE DEVICE WAS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840927 ↗
• MalfunctionJul 26, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SURGEON NOTICED THAT DURING USE AND THREAD INSERTION THE DEVICE WAS DEFECTIVE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19840818 ↗
• MalfunctionJun 18, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A DID SURGERY THE KNOB ONLY WORKED INTERMITTENTLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558746 ↗
• MalfunctionJun 11, 2024Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT, DURING A ROTATOR CUFF REPAIR, THE ROLLERS ON THE SUTURE LASSO DID NOT WORK. THE SUTURE WAS NOT GOING OUT. THE SURGEON WAS NOT ABLE TO SCROLL THE ROLLERS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE KPIL (B)(6) 2024: IT WAS FURTHER REPORTED THAT THE SURGEON WAS USING THE SUTURE LASSO ON THE PATIENT TO PASS HIS SUTURES BUT THE ROLLERS WERE OFF AND DID NOT ROLL. NO PART OF THE DEVICE BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19508409 ↗
• MalfunctionJun 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY THE FIBERSTICK OF THE DEVICE COULD NOT BE PUSHED FORWARD AND BECAME ENTANGLED WITH THE QUICK-PASS WHEELS AND JAMMED ON THE WHEEL. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19451891 ↗
• MalfunctionJun 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY THE FIBERSTICK OF THE DEVICE COULD NOT BE PUSHED FORWARD AND BECAME ENTANGLED WITH THE QUICK-PASS WHEELS AND JAMMED ON THE WHEEL. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19451485 ↗
• MalfunctionJun 3, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SHOULDER ROTATOR CUFF REPAIR SURGERY THE FIBERSTICK OF THE DEVICE COULD NOT BE PUSHED FORWARD AND BECAME ENTANGLED WITH THE QUICK-PASS WHEELS AND JAMMED ON THE WHEEL. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19450922 ↗
• MalfunctionMay 6, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A MENISCAL SUTURE RAMP LESION SURGERY THE DEVICE WAS DEFECTIVE. THE SUTURE DEPLOYMENT WHEEL WAS LOCKED AND IT WAS IMPOSSIBLE TO UNWIND THE SUTURE INTRAARTICULARLY. NO PART OF THE DEVICE BROKE OFF. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19247003 ↗
• MalfunctionApr 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A MENISCUS SURGERY THE THREAD COULD NOT BE MOVED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19136588 ↗
• MalfunctionApr 11, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED ON 07/26/2022 BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-6068-25L SUTURE LASSO IMPLANT WOULD NOT DEPLOY. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089389 ↗
• MalfunctionJan 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A MENISCUS RAMP LESION REPAIR SURGERY THE SUTURE HAS BROKEN FROM THE DISPENSER. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE AVOE 23-JAN-2024 IT WAS FURTHER REPORTED THAT THE SUTURE BROKE WHILE SEWING. IT HAPPENED INSIDE PATIENT, BUT ALL PARTS WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18594689 ↗
• MalfunctionNov 7, 2023Defective Device; Physical Resistance/Sticking; Defective Device; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RAMP SUTURE SURGERY THE QUICKLASSO ARE OBSTRUCTED AND ANY SUTURE CANNOT GO OUT OF OUR DEVICE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085587 ↗
• MalfunctionAug 23, 2023Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE WIRE COULD NOT BE INSERTED INTO THE LASSO PASS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17604876 ↗
• MalfunctionAug 2, 2023Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT KNEE SURGERY THE WIRE COULD NOT BE FED THROUGH THE INSTRUMENT USING THE KNOB. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17443927 ↗
• MalfunctionAug 2, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A RAMP LESION SURGERY A DEVICE WAS OPENED AND IT WAS IMPOSSIBLE TO GET THE PDS 0 SUTURE UP INTO THE HOOK. THE SAME THING WAS TRIED WITH PDS 1, BUT THE SUTURE JAMMED IN THE KNURLS AND WOULDN'T COME OUT AT THE END OF THE HOOK. THIS WAS TRIED AGAIN WITH 2 OTHER HOOKS BUT THE SURGEON HAD THE SAME PROBLEM. ALL 3 DEVICES AR-6068-25L WERE FROM THE SAME BATCH 3030128765. ANOTHER HOOK WITH THE REF. ((B)(4).) WAS REQUIRED TO BE ABLE TO SUTURE THE MENISCUS. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (4068-25TLF). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17442597 ↗
• MalfunctionJul 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE TIP OF THE GUIDE WIRE BROKE OFF INSIDE THE PATIENT'S KNEE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245860 ↗
• MalfunctionMay 16, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SURGEON WAS NOT ABLE TO UNWOUND THE THREAD. THE DEVICE IS BLOCKED ON 1CM OF THREAD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THAT DUE TO THE CHANGE OF THE DEVICE THE PROCESS NEEDED TO BE CHANGED. NO FURTHER INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16937903 ↗
• InjuryFeb 13, 2023Output Problem; Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SURGEON WAS NOT ABLE TO UNWOUND THE THREAD. THE DEVICE IS BLOCKED ON 1CM OF THREAD. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS FURTHER REPORTED THAT DUE TO THE CHANGE OF THE DEVICE THE PROCESS NEEDED TO BE CHANGED. NO FURTHER INFORMATION WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361785 ↗