LUPINE ORTHOCORD 210712Recalls & reported problems

Summary

The FDA's MAUDE database contains 357 adverse event reports that list this exact device (DI 10886705001101), received between May 9, 2018 and Sep 18, 2026 — classified as 33 injuries, 324 malfunctions.

The most frequently reported specific device problem is “Break” (143 reports).

21 other recalls cover devices cleared under the same FDA submission (K040827, K070925, 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 357 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50823355 ↗
• MalfunctionSep 18, 2026Use of Device Problem; Detachment of Device or Device Component

  It was reported that during biceps tenodesis surgery, the LUPINE ORTHOCORD device sutures came detached from the loop part of the anchor body, thus resulting in failure. There was no delay in the procedure reported. There were no reports of injuries, medical intervention or prolonged hospitalization.  The exact date of the event was unknown. However, it was reported that the event occurred in 2026. All available information has been disclosed.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818355 ↗
• MalfunctionSep 14, 2026Break; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50758121 ↗
• MalfunctionSep 1, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50542585 ↗
• MalfunctionAug 19, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50330929 ↗
• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE TIP OF THE ANCHOR BROKE OFF. REMOVED ALL THE BROKEN PARTS. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537202 ↗
• MalfunctionMay 29, 2026Migration

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY, THE LUPINE ORTHOCORD DEVICE ANCHOR PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25330945 ↗
• MalfunctionMay 1, 2026Material Fragmentation; Device Damaged Prior to Receipt by User; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LUPINE ORTHOCORD DEVICE WAS FRACTURED AND FELL APART. IT WAS NOTED IN THE SERVICE ORDER THAT THE DURING THE SURGERY, THE DEVICE DETACHED FROM THE ANCHOR AND THE ANCHOR WAS DEFORMED INSIDE THE PACKAGE. IT WAS NOTED THAT THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 25058656 ↗
• MalfunctionMay 1, 2026Device Damaged Prior to Receipt by User; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING SERVICE AND EVALUATION, IT WAS DETERMINED THAT THE LUPINE ORTHOCORD DEVICE FELL APART. IT WAS NOTED IN THE SERVICE ORDER THAT THE DURING THE SURGERY, THE DEVICE DETACHED FROM THE ANCHOR AND THE ANCHOR WAS DEFORMED INSIDE THE PACKAGE. IT WAS NOTED THAT THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 25058654 ↗
• MalfunctionApr 22, 2026Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY RECONSTRUCTION SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINE ORTHOCORD DEVICE ANCHOR BROKE OFF. ALL BROKE PARTS WERE REMOVED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24956930 ↗
• MalfunctionApr 21, 2026Product Quality Problem; Material Deformation

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LUPINE BR DS W/ORTHCRD DEVICE WAS DEFORMED/BENT. IT WAS INITIALLY REPORTED THAT BEFORE A PATELLAR DISLOCATION SURGERY, THE PACKAGING HAD BEEN OPENED AND NOT USED. THE ANCHOR WAS MISSING. 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 24939967 ↗
• MalfunctionMar 13, 2026Migration

  IT WAS REPORTED THAT DURING AN UNKNOWN ARTHROSCOPIC PROCEDURE THAT THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE PULLED OUT OF THE TISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 10 MIN DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24590744 ↗
• MalfunctionMar 11, 2026Migration

  IT WAS REPORTED THAT DURING A REPAIR OF ANTERIOR TALOFIBULAR LIGAMENT SURGERY, THE LUPINE BR DS W/ORTHCRD ANCHOR WAS PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A FIVE MINUTE DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24575811 ↗
• MalfunctionMar 11, 2026Break

  IT WAS REPORTED THAT DURING A SOFT TISSUE REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE LUPINE BR DS W/ORTHCRD DEVICE ANCHOR BROKE 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 24571492 ↗
• MalfunctionFeb 23, 2026Break

  IT WAS REPORTED THAT DURING LABRAL REPAIR SURGERY, THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE 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 24421157 ↗
• MalfunctionFeb 18, 2026Break; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE LUPINE BR DS W/ORTHCRD DEVICE WAS BROKEN (2+ PIECES) : DEVICE FRACTURED. IT WAS INITIALLY REPORTED THAT PRIOR TO A LEFT ANKLE ARTHROSCOPIC LIGAMENT REPAIR SURGERY, UPON OPENING THE PACKAGING, IT WAS NOTED THAT THE ANCHOR WAS DEFORMED. THE DEVICE WAS NOT USED. THREE REPLACEMENT DEVICES HAD THE SAME ISSUE. 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 24377020 ↗
• MalfunctionJan 28, 2026Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY LUPINE BR DS W/ORTHCRD WAS DEFORMED AND THEY REMOVED THE ANCHOR FROM THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24198086 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, THE LUPINE BR DS W/ORTHCRD DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184122 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER BRACHIOPLASTY/LABRAL FIXATION SURGERY, THE GRYPHON P BR DS ANCHOR W/OC ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. IT WAS REPORTED THAT THE USER CHANGED TO ANOTHER THREE (4.75 HEALIX ADVANCE KNTLSS BR, LUPINE BR DS W/ORTHCRD QTY. 2) TO CONTINUE THE SURGERY, HOWEVER THE SAME PROBLEM HAPPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131922 ↗
• MalfunctionJan 21, 2026Break

  IT WAS REPORTED THAT DURING SHOULDER BRACHIOPLASTY/LABRAL FIXATION SURGERY, THE GRYPHON P BR DS ANCHOR W/OC ANCHOR DEVICE WAS BROKEN OFF, REMOVED ALL THE BROKEN PARTS. IT WAS REPORTED THAT THE USER CHANGED TO ANOTHER THREE (4.75 HEALIX ADVANCE KNTLSS BR, LUPINE BR DS W/ORTHCRD QTY. 2) TO CONTINUE THE SURGERY, HOWEVER THE SAME PROBLEM HAPPENED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24131921 ↗
• MalfunctionJan 8, 2026Break

  IT WAS REPORTED THAT DURING TALOFIBULAR LIGAMENT SURGERY, THE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE WAS BROKEN OFF. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS A 5 MINUTE DELAY IN SURGERY DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24006454 ↗
• MalfunctionJan 7, 2026Break

  IT WAS REPORTED THAT DURING A PATELLAR LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT WHEN TIGHTENED THE SUTURE ON THE LUPINE BR DS W/ORTHCRD DEVICE BROKE OFF. 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 23989054 ↗
• MalfunctionJan 7, 2026Material Deformation

  IT WAS REPORTED THAT DURING A PATELLAR LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE LUPINE BR DS W/ORTHCRD DEVICE WAS DEFORMED. THE ANCHOR WAS REMOVED FROM THE PATIENT. 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 23988943 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING REPAIR OF THE TALOFIBULAR LIGAMENT, THE SUTURE ON THE LUPINE BR DS W/ORTHCRD DEVICE DETACHED FROM ITS ANCHOR. THERE WAS A TEN-MINUTE DELAY 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 23936209 ↗
• MalfunctionDec 30, 2025Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE SURGEON IMPLANTED ONE LUPINE BR DS W/ORTHCRD ANCHOR DEVICE AND WENT TO PULL ON THE SUTURES AND THE SUTURES PULLED RIGHT THROUGH THE ANCHOR WITHOUT UNLOADING ALMOST AS IF THE POST HOLDING THE SUTURE INSIDE THE ANCHOR BROKE. THE ANCHOR REMAINED IN THE PATIENT. A SECOND ANCHOR FROM THE SAME LOT FAILED IN THE SAME MANNER. THERE WAS TWENTY-MINUTE DELAY TO THE SURGICAL PROCEDURE. 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 23921521 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K040827, K070925, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-1163-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine (Panalok) Loop Arthro #2 Panacryl Catalog Number: 210705 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1167-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Ethibond Catalog Number: 210710 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1170-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop O-C violet Catalog Number: 222980 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1165-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop Plus Anchor w/Orthocord Catalog Number: 210708 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1162-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine (Panalok) Loop Arthro #2 Ethibond Catalog Number: 210704 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1166-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LupineLoopPlus Anchor w/Orthocord DS Catalog Number: 210709 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1169-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR DS W/ORTHCRD Catalog Number: 210712 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1168-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek LUPINE BR W/ORTHCORD Catalog Number: 210711 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1171-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek Lupine Loop DS w/Orthocord Catalog Number: 222981 The Lupine Anchor System is indicated for use in soft tissue bone fixation.
• Z-1164-2012 · Jan 27, 2012 · Terminated
  Depuy Mitek- Lupine Loop Plus Anchor w/ Panacryl Catalog Number: 210707 The Lupine Anchor System is indicated for use in soft tissue bone fixation.

…and 6 more.