Y-KNOT Y1802Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20845854021672), received between Feb 5, 2024 and Dec 15, 2025 — classified as 1 injury, 2 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.

• MalfunctionDec 15, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y1802, FLEX 1.8 MM ALL-SUTURE ANCHOR W/2 #2 (5 METRIC) HI-FI SUTURE WAS BEING USED ON (B)(6) 2025 AND "AFTER OPENING THE PACKAGE AND PREPARING TO ENTER THE BONE PASSAGE, WHEN THE HANDLE WAS TAPPED, THE SMALL TEETH AT THE FRONT END BROKE, MAKING THIS CONSUMABLE UNUSABLE. IT IS NOW SENT BACK TO THE AFTER-SALES CENTER IN BEIJING¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. PER FURTHER ASSESSMENT IT WAS REPORTED THAT THE "SMALL TEETH" WERE "PART OF INSERTER". THE FRAGMENTS FELL INTO THE SURGICAL SITE AND WERE REMOVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801830 ↗
• MalfunctionJun 16, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, Y1802, FLEX 1.8 MM ALL-SUTURE ANCHOR W/2 #2 (5 METRIC) HI-FI SUTURE, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿DURING THE GLENOID SURGERY, A SECTION OF THE FORKED END OF THE INSTRUMENT'S IMPLANTATION ROD BROKE OFF INSIDE THE BODY. IT WAS REMOVED USING FORCEPS, AND THE SURGERY WAS NOT DELAYED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210093 ↗
• InjuryFeb 5, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE Y1802, Y-KNOT FLEX 1.8MM ALL-SUTURE ANCHOR DEVICE WAS BEING USED DURING A KNEE MENISCUS PRESERVATION SURGERY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED ¿Y1802 WAS USED FOR KNEE CENTRALIZATION UNDER DOCTORS¿ SURGERY. AT THAT TIME, THE FORK PART AT THE TIP OF THE INSERTER WAS DAMAGED. DAMAGED METAL REMAINS IN THE BODY.¿ FURTHER ASSESSMENT QUESTIONING FOUND THAT THERE WAS NO DELAY REPORTED AND THERE WAS NO MEDICAL/SURGICAL INTERVENTION. CURRENTLY, IT IS UNKNOWN IF THERE ARE ANY PLANS TO REMOVE THE FRAGMENT FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THE CURRENT STATUS IF THE PATIENT WAS REPORTED AS UNKNOWN. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO THE PATIENT RETAINING A FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18639316 ↗