Argo Knotless K475Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20845854649821), received between Nov 22, 2021 and Nov 13, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE K475, 4.75 MM ARGO KNOTLESS ANCHOR WAS BEING USED ON (B)(6) 2025 DURING AN RCR AND THE ¿SURGEON WAS FINISHING HIS CUFF REPAIR USING A 4.75MM ARGO (K475 - 1443004). HE HAD PASSED X2 RIBBONS THOUGH THE CUFF FOR THE MEDIAL ROW AND THEN ANCHORED ALL 4 LIMBS OF RIBBON INTO THIS ARGO. HE HAD PRE-PUNCHED WITH A DISPOSABLE PUNCH (K4755DTBP - 1457856) WHICH WORKED WELL. HE REMOVED THE ARGO AFTER SCREWING THE ANCHOR IN WHICH WORKED GREAT. WHEN HE USED THE KATANA SUTURE CUTTER TO CUT THE LIMBS OF SUTURE, HE MOVED THE CAMERA BACK TO THE WORKING SITE WHERE HE COULD SEE THE KATANA WORKING AND NOTICED A FREE METAL PIECE. AT FIRST, HE THOUGHT THE KATANA HAD COME APART BUT IT WAS THE END OF THE ARGO THAT HAD DISLODGED FROM THE ANCHOR WHEN HE REMOVED THE HANDLE. HE WASN'T WORRIED. WE CHECKED THE REPAIR AND THE ANCHOR WAS WORKING WELL LIKE IT SHOULD. WE THEN MADE SURE THAT WAS ALL THAT WAS MISSING AND TOOK PHOTOS OF THE ANCHOR AND THE DISLODGED PIECE. PROCEDURE WAS COMPLETED WHEN THIS INCIDENT HAPPENED. WE ENSURED NO METAL WAS LEFT IN THE PATIENT." THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT AND THIS EVENT DID NOT CAUSE A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541418 ↗
• MalfunctionSep 26, 2024Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT K475, 4.75 MM ARGO KNOTLESS ANCHOR WAS BEING USED ON (B)(6) 2024 DURING A ROTATOR CUFF REPAIR PROCEDURE WHEN IT WAS REPORTED ¿WELD BROKE AND HEX WAS FLOATING AROUND IN THE SHOULDER, CAUSED 5¿10-MINUTE CASE DELAY.¿. FURTHER ASSESSMENT FOUND THAT THE FRAGMENT WAS REMOVED WITH THE USE OF GRASPERS. THE PROCEDURE WAS COMPLETED AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309694 ↗
• MalfunctionNov 22, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, K475, 4.75MM ARGO KNOTLESS ANCHOR, WAS BEING USED ON APPROXIMATELY (B)(6) 2021 DURING A ROTATOR CUFF REPAIR PROCEDURE AND THE ¿TIP WAS BROKEN DURING ANCHOR INSERTION.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THERE WAS MAYBE A 5 MINUTE DELAY TO LOCATE AND REMOVE THE PIECE AND THE PROCEDURE WAS COMPLETED WITH A BACKUP. AFTER FURTHER ASSESSMENT IT WAS FOUND, ¿THE TIP DID FALL INTO THE INCISION SITE, WE WERE ABLE TO RETRIEVE THE BROKEN TIP AND UPON INSPECTION IT WE WERE ABLE TO FIT BOTH PARTS BACK TOGETHER TO ENSURE THERE WERE NO OTHER SMALLER PIECES. THE PIECE WAS RETRIEVED USING A GRASP.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12858282 ↗