Y-KNOTRecalls & reported problems across all models

We found 14 models of Y-KNOT by Conmed Corporation in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2017 and Sep 4, 2026 — classified as 28 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (52 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Y-KNOT problems

Y-KNOT models

14 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Y-KNOT Y1301

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  30 reports
• Y-Knot YRC02

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  7 reports
• Y-KNOT Y1802A

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  5 reports
• Y-Knot YP1802

  Fastener, fixation, nondegradable, soft tissue
  5 reports
• Y-KNOT YP1301RW

  Fastener, fixation, nondegradable, soft tissue
  4 reports
• Y-KNOT Y1802

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  3 reports
• Y-Knot YRC03

  FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
  3 reports
• Y-Knot YPRC02R

  Fastener, fixation, nondegradable, soft tissue
  2 reports
• Y-KNOT Y-BP28

  ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
  1 report
• Y-Knot YRC02STA

  Fastener, fixation, nondegradable, soft tissue
  1 report
• Y-Knot YRC02STB

  Fastener, fixation, nondegradable, soft tissue
  1 report
• Y-KNOT YRC02N

  Fastener, fixation, nondegradable, soft tissue
  1 report
• Y-KNOT YRC02N

  Fastener, fixation, nondegradable, soft tissue
  1 report
• Y-Knot YP1301RB

  Fastener, fixation, nondegradable, soft tissue
  1 report

Recent Y-KNOT adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Conmed Japan reported on behalf of the customer that the Y1301 FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, was found after post-operative care when a Peroneus superior retinaculum repair (Das-De method) procedure was performed on an unknown date when it was reported, ¿a Y-Knot Flex anchor (1.3 mm diameter, with one No. 2 suture) was inserted into the tibia. It has been approximately seven months since the surgery, yet the patient continues to experience persistent bone pain at the anchor insertion site.¿. Further assessment questioning confirmed that the device did not malfunction during this procedure. The patient had no pathological conditions of bone, no restriction for healing and no foreign body sensitivities. The procedure was completed and it was also reported ¿according to the doctor, they will monitor the situation for about a year and then reassess whether removal is necessary.¿. There was no report of medical intervention, or extended hospitalization for the patient. This report is being raised due to the reported injury due to the patient obtaining post operative pain at the insertion site.

  Patient problems: Implant Pain

  MAUDE report 50614234 ↗
• InjuryAug 26, 2026Material Fragmentation

  The distributor reported on behalf of their customer that the device, Y-BP28, Y-Knot RC Broaching Punch, 2.8 mm, was used during a RCR procedure on (b)(6) 2026 when it was reported, ¿During Surgery, while the punch was being struck with a mallet, the tip of the punch broke off and became embedded in the bone. The complaint device was disposed of by the hospital and is therefore not available for return. The procedure was successfully completed using a replacement device Y-BP28. No adverse impact on the patient was reported.¿. There was no report of medical intervention or hospitalization for the patient. The procedure was completed as planned.This report is being raised due to the reported injury of foreign body left in patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50450534 ↗
• MalfunctionAug 17, 2026Material Fragmentation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50273395 ↗
• InjuryAug 11, 2026Material Fragmentation

  The distributor reported on behalf of the customer that the device YP1802, Y-KNOT PRO FLEX 1.8 MM ANCHOR, TWO NO. 2 HI-FI was being used and ¿On (b)(6) 2026, Dr. from (b)(6) Hospital in (b)(6) was performing a shoulder joint arthroscopy-based labrum repair surgery and during the process, he discovered that the insertion rod head of the anchor had a missing tooth after the anchor was implanted. The broken tooth remained in the patient's body.¿ There was no impact or injury to the patient or user. This report is being raised due to the reported injury of fragment of the device remains in the patient.

  Patient problems: Foreign Body In Patient

  MAUDE report 50206929 ↗
• InjuryAug 7, 2026Material Fragmentation

  Patient problems: Foreign Body In Patient

  MAUDE report 50176648 ↗
• MalfunctionMar 19, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, WAS USED DURING AN ARCR PROCEDURE ON (B)(6) 2026 WHEN IT WAS REPORTED, ¿WE PERFORMED THE DRILLING AND ANCHOR INSERTION AS PER THE STANDARD PROCEDURE. AFTER ANCHORING, WE NOTICED THAT ONE SIDE OF THE BIFURCATED TIP OF THE INSERTER HAD FRACTURED. THE BROKEN FRAGMENT IS PRESUMED TO HAVE REMAINED ON THE FLAT-BLADE PORTION OF THE ANCHOR, OR, IF EXTREMELY SMALL, MAY HAVE BEEN CARRIED OUT OF THE JOINT SPACE WITH THE IRRIGATION FLOW.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT A REPORTED DELAY. FURTHER ASSESSMENT FROM THE REPORTER STATED, ¿THE FRAGMENTATION WAS NOT LEFT IN 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 24637085 ↗
• MalfunctionFeb 4, 2026Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, YRC02, RC ALL-SUTURE ANCHOR, WITH HI-FI SUTURES WAS BEING USED ON (B)(6) 2026, THE HOSPITAL NEWLY PURCHASED THE YRC02 Y-KNOT ALL-SUTURE ANCHOR. DURING THE SHOULDER JOINT SURGERY, THE FRONT END OF THE ANCHOR BROKE WHEN THE ANCHOR BODY WAS INSERTED, CAUSING THE FRONT END OF THE WIRE TO FALL OFF AND MAKING THE ANCHOR UNUSABLE.¿ THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. PER FURTHER ASSESSMENT IT WAS REPORTED THAT WHAT WAS MEANT BY THE "WIRE" WAS THE INSERTER. THE INSERTER FRAGMENTED AND FELL INTO THE SURGICAL SITE AND WAS RETRIEVED." 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 24258867 ↗
• InjuryJan 26, 2026Material Fragmentation

  A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE YP1802, Y-KNOT PRO FLEX 1.8 MM ANCHOR, TWO NO. 2 HI-FI DEVICE WAS USED IN A SURGERY FOR RECURRENT SHOULDER DISLOCATION ON (B)(6) 2026, AND ¿THE NORMAL DRILL BIT WAS IMPLANTED WITH AN OPEN CIRCUIT, AND THE ANGLE WAS NOT DEVIATED. HOWEVER, THE OPENING AT THE HEAD END BROKE.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE AND A DELAY OF ONE HOUR. FURTHER ASSESSMENT FOUND THE DEVICE FRAGMENTED AND FELL INTO THE SURGICAL SITE AND FRAGMENTS WERE NOT RETRIEVED. "THE FRAGMENTS HAVE ALREADY PENETRATED INTO THE BONES AND ARE DIFFICULT TO REMOVE. THE HOSPITAL HAS COMMUNICATED WITH THE PATIENT TO OBTAIN THEIR UNDERSTANDING AND WILL CONDUCT REGULAR FOLLOW-UPS AFTER THE SURGERY.". THE PATIENT WAS HOSPITALIZED AS "A NORMAL POSTOPERATIVE HOSPITAL STAY, NOT BECAUSE OF THE FRACTURE OF THE EQUIPMENT.". THE PATIENT'S STATUS IS DESCRIBED AS "IN CLINICAL COMMUNICATION AND UNDERSTANDING". THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF RETAINED FOREIGN BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24176418 ↗
• InjuryJan 7, 2026Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, YP1301RW, Y-KNOT PRO FLEX 1.3 MM ANCHOR, RIBBON WHITE/BLACK, WAS BEING USED DURING AN ABR PROCEDURE ON 18DEC25 WHEN IT WAS REPORTED, ¿ONE SIDE OF THE U-SHAPED PART OF THE SHAFT AT THE TIP OF THE ANCHOR BROKE. THE BONE WAS HARD, SO IT WAS NECESSARY TO USE A LITTLE FORCE WHEN INSERTING IT, WHICH IS THOUGHT TO HAVE CAUSED MORE STRESS THAN NECESSARY TO BE PLACED ON THE TIP. THIS HAS BEEN OCCURRING FREQUENTLY IN RECENT CASES OF DISLOCATION, AND USERS ARE CALLING FOR IMPROVEMENTS TO THE TIP STRENGTH.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED, AND IT WAS REPORTED THAT THE DEVICE FRAGMENTED IN THE PATIENT AND THE FRAGMENTATION WAS NOT RETRIEVED. THE REPORTER DID NOT EXPLAIN WHY THE FRAGMENTATION WAS NOT RETRIEVED. THERE WAS NO DELAY TO THE PROCEDURE, AND THE PROCEDURE WAS COMPLETED AS PLANNED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF FOREIGN BODY LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23988644 ↗
• MalfunctionJan 5, 2026Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, YP1802, Y-KNOT PRO FLEX 1.8 MM ANCHOR, TWO NO. 2 HI-FI, WAS USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE HOSPITAL PURCHASED YP1802 Y-KNOT ALL-SUTURE ANCHOR ON DECEMBER 10, 2025. AFTER UNPACKING, WHEN PREPARING TO ENTER THE BONE TUNNEL, THE FRONT NAIL BODY (IT IS THE INSERTER PART THAT HAS BROKEN) WAS DAMAGED AFTER TAPPING THE HANDLE, RESULTING IN THE INABILITY TO USE THE CONSUMABLE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED, AND IT WAS FOUND THAT THE MEANING OF BROKEN WAS THAT THE INSERTER FRAGMENTED DURING USE ON THE PATIENT. FRAGMENTATION FELL INTO THE PATIENT AND WAS RETRIEVED WITH FORCEPS. 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 23957143 ↗
• MalfunctionDec 18, 2025Material Fragmentation; Material Fragmentation

  THE DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, WAS USED DURING AN ARTHROSCOPIC SURGERY, WITH THE IMPLANT SITE BEING THE ANKLE JOINT PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE HOSPITAL NEWLY PURCHASED Y1301 FULL-SUTURE ANCHOR BOLTS. AFTER BEING HAMMERED IN, THE SMALL TEETH AT THE FRONT END BROKE, MAKING THIS CONSUMABLE UNUSABLE.¿. FURTHER ASSESSMENT WAS REQUESTED AND REPORTED ADVISED, ¿WHEN THE ANCHOR IS IMPLANTED, THE FRONT END FORKS AND IS SOFT, AND THE IMPLANTED PART OF THE ANCHOR BODY IS LONG. DURING THE POSITIONING PROCESS, THE DIRECTION IS PRONE TO DEVIATION, AND THE FRONT END BREAKS AFTER HITTING THE BONE." A COMPONENT HAD FALLEN INTO THE SURGICAL SITE AND WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT ANY 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 23837067 ↗
• MalfunctionDec 16, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE THAT THE Y1301 FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC), HI-FI SUTR DEVICE WAS BEING USED ON (B)(6) 2025. DURING AN ARTHROSCOPIC PROCEDURE ON (B)(6) 2025. WHEN IT WAS REPORTED ¿THE SMALL TEETH AT THE FRONT END BROKE.". FURTHER ASSESSMENT QUESTIONING FOUND THAT "THE INSERTER PART BROKE" AND THE FRAGMENTS WERE RETRIEVED WITH MEDICAL FORCEPS. 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 DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815593 ↗
• 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 ↗
• MalfunctionNov 17, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER REPORTED THAT THE DEVICE, YP1301RW, Y-KNOT PRO FLEX 1.3 MM ANCHOR, RIBBON WHITE/BLACK, WAS BEING USED DURING AN ABR PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿WHEN USING THE THIRD YKNOT, THE TIP OF THE INSERTER BROKE. THERE WAS NO PROBLEM WITH THE USAGE PROCEDURE, AND THE BONE WAS NOT HARD, SO THE CAUSE WAS UNCLEAR. HOWEVER, EVEN WHEN EXAMINING THE TIP OF AN ANCHOR THAT WAS INSERTED NORMALLY WITHOUT BREAKING, THE U-SHAPED PORTION OF THE INSERTER WAS SLIGHTLY EXPANDED AFTER INSERTION, SUGGESTING THAT A SIGNIFICANT AMOUNT OF FORCE WAS APPLIED." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT WAS REQUESTED; HOWEVER, TO DATE CONMED HAS NOT RECEIVED A RESPONSE. 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 23569508 ↗
• MalfunctionOct 21, 2025Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, Y1301, FLEX 1.3MM ALLSUTURE ANCH W/1-#2 WHT/BL (5METRIC) HI-FI SUTR, WAS BEING USED DURING A MBO PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿AFTER GUIDE INSERTION AND DRILLING, DURING THE PROCESS OF INSERTING THE ANCHOR TO THE BONE USING A MALLET, THE SUTURE BROKE WHILE PULLING IT OUT TO CHECK FIXATION. THE ANCHOR AND SUTURE WERE NOT RETURNED AS THEY WERE DISPOSED OF AT A HOSPITAL. AFTER PRODUCT INSPECTION, IT WAS FOUND THAT ONE UNIT HAD A BROKEN SHAFT". FURTHER ASSESSMENT THAT THE FRAGMENTATION OF THE DEVICE HAD FALLEN INTO THE SURGICAL SITE AND WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE CAUSING A 15-MINUTE DELAY. 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 23346079 ↗

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