GRYPHON ORTHOCORD 210814Recalls & reported problems

Summary

The FDA's MAUDE database contains 110 adverse event reports that list this exact device (DI 10886705001286), received between Jul 19, 2018 and Sep 30, 2026 — classified as 3 injuries, 107 malfunctions.

The most frequently reported specific device problem is “Break” (80 reports).

7 other recalls cover devices cleared under the same FDA submission (K090124, K150209); 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. 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 110 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Break

  This is report 1 of 4 for (b)(4).It was reported that during an unknown surgery, the suture of a 4.75 HEALIX ADVANCE KNTLSS BR device broke off when tightened. An identical device was used and the suture broke off again. A third identical device was used to complete the surgery. It was further reported that when the GRYPHON P BR ANCHOR W/OC device was tightened the suture broke off and an identical device was used to continue the surgery. When the 4.5 HEALIX ADVANCE BR W/OCORD anchor was tightened the anchor broke off. All broken parts were removed. An identical device was used to complete the surgery. There were no reports of injuries, medical intervention or prolonged hospitalization. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50951534 ↗
• MalfunctionSep 10, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50716044 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GRYPHON P BR ANCHOR W/OC DEVICE HAD BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570938 ↗
• MalfunctionFeb 5, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC SHOULDER STABILIZE PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE (QTY.3) DID NOT HOLD IN THE DRILLHOLE. ANOTHER DEVICE WITH A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270466 ↗
• MalfunctionFeb 5, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC SHOULDER STABILIZE PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE (QTY.3) DID NOT HOLD IN THE DRILLHOLE. ANOTHER DEVICE WITH A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270457 ↗
• MalfunctionFeb 5, 2026Difficult to Advance

  IT WAS REPORTED THAT DURING A ARTHROSCOPIC SHOULDER STABILIZE PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE (QTY.3) DID NOT HOLD IN THE DRILLHOLE. ANOTHER DEVICE WITH A DIFFERENT LOT WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER PROBLEMS. THERE WERE NO REPORTS OF SURGICAL DELAY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24270452 ↗
• MalfunctionDec 9, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ACHILLES REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GRYPHON P BR ANCHOR W/OC DEVICE BROKE OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758154 ↗
• MalfunctionNov 17, 2025Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE GRYPHON P BR ANCHOR W/OC DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23568054 ↗
• MalfunctionSep 12, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY SURGICAL PROCEDURE IT WAS OBSERVED THAT THE EXPRSEW III GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN WERE REMOVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23037597 ↗
• MalfunctionSep 12, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23036836 ↗
• MalfunctionAug 22, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPY PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE SUTURE WAS BROKE OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22874673 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553873 ↗
• MalfunctionJul 21, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE JOINT LIGAMENT REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE TIP OF THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. THE USER CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22553872 ↗
• MalfunctionJun 30, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS BROKEN. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22356643 ↗
• MalfunctionJun 4, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE TIP OF ANCHOR WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22143239 ↗
• MalfunctionMay 15, 2025Migration; Migration

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22030152 ↗
• MalfunctionOct 18, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING AN ARTHROSCOPY PROCEDURE IT WAS OBSERVED THAT GRYPHON P BR ANCHOR W/OC DEVICE BROKE OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20486152 ↗
• MalfunctionSep 16, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN HUNGARY THAT DURING A SHOULDER ARTHROSCOPIC LABRAL REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE GRYPHON P BR ANCHOR W/OC DEVICE SUTURE WAS BROKE OFF WHEN TIGHTENING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20224166 ↗
• MalfunctionSep 6, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A LABRAL REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN THE GRYPHON P BR ANCHOR W/OC SUTURE DEVICE WAS TIGHTENED, THE SUTURE WAS BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20161816 ↗
• MalfunctionJun 5, 2024Break; Break

  THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON P BR ANCHOR W/OC DEVICE BROKE THEN REMOVED ALL THE BROKEN PARTS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467777 ↗
• MalfunctionApr 24, 2024Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4) . IT WAS REPORTED FROM CHINA THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON P BR ANCHOR W/OC DEVICE BROKE THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176543 ↗
• MalfunctionApr 24, 2024Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4) . IT WAS REPORTED FROM CHINA THAT DURING AN ANKLE LIGAMENT REPAIR PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON P BR ANCHOR W/OC DEVICE BROKE THEN REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19176541 ↗
• MalfunctionApr 3, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL FROM CHINA THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE GRYPHON P BR ANCHOR W/OC DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19031045 ↗
• MalfunctionMar 26, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A HIP SURGERY SURGICAL PROCEDURE ON (B)(6) 2024 THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18981104 ↗
• MalfunctionMar 12, 2024Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, THE GRYPHON P BR ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886337 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090124, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-2210-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON P BR DS Anchor w/ORTHOCORD Product Code: 210813 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic
• Z-2211-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON P BR Anchor w/ORTHOCORD Product Code: 210814 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bicep