BIOKNOTLESS ORTHOCORD ETHIBOND 212726Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886705002122), received between Jul 24, 2018 and Dec 8, 2022 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K062170, 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.

Recalls naming this device

1. Apr 13, 2023Class IIOpen, Classified

   IFU Warning: Applying bending force and/or bending force with impaction to the BIOKNOTLESS Anchor Inserter may cause a fragment of the inserter tip to break off during use and be retained in the patient. broken BIOKNOTLESS Anchor inserter tip detected during surgery may require removal, potentially causing bone damage and longer surgery time

   Z-1679-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A BANKART REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE BIOKNOTLESS PLUS W/ORTHOCORD DEVICE BROKE THAT REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15942351 ↗
• MalfunctionNov 23, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN SOUTH KOREA THAT DURING A BANKART REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR TIP ON THE BIOKNOTLESS PLUS W/ORTHOCORD DEVICE BROKE THAT REMAINED INSIDE THE PATIENT. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15857475 ↗
• InjuryFeb 7, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN UNKNOWN PROCEDURE THAT THE THREADED PORTION OF THE INSERTED REMAINED IN THE BIOKNOTLESS PLUS W/ ORTHOCORD AFTER INSERTION. THERE'S NO ADDITIONAL INFORMATION AT THE TIME OF THE CALL. NO PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION PROVIDED BY THE AFFILIATE REPORTED THE EVENT OCCURRED DURING A SHOULDER ARTHROSCOPY AND THE CASE WAS COMPLETED DECIDING THE KEEP THE ANCHOR IN THE GLENOID OF THE PATIENT WITH THE TIP OF THE INSERTED STILL INSIDE. IT WAS REPORTED THE SURGEON DID NOT ATTEMPT TO REMOVE THE INSERTER FROM THE PATIENT AND THERE ARE NO KNOWN ADVERSE EFFECTS TO PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9683924 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S BIOKNOTTLESS ANCHOR WITH ORTHOCORD WITH A QUANTITY OF TWO FAILED DURING A LABRUM REPAIR SURGICAL PROCEDURE. THE SHAFT BENT WHEN PUSHING THE ANCHOR INTO THE BONE WITH HAND, NO TAP ON BOTH DEVICES. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. THERE WAS NO NEW BONE HOLE NEEDED AND BONE QUALITY WAS HARD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8270869 ↗
• MalfunctionJan 23, 2019Material Twisted/Bent; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S BIOKNOTTLESS ANCHOR WITH ORTHOCORD WITH A QUANTITY OF TWO FAILED DURING A LABRUM REPAIR SURGICAL PROCEDURE. THE SHAFT BENT WHEN PUSHING THE ANCHOR INTO THE BONE WITH HAND, NO TAP ON BOTH DEVICES. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE FROM A DIFFERENT LOT. THERE WAS NO NEW BONE HOLE NEEDED AND BONE QUALITY WAS HARD. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8270650 ↗
• MalfunctionOct 30, 2018Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE SURGEON BENT THE BIOKNOTLESS ANCHORS DEVICES TRYING TO FIXATE THEM WITH A PATIENT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE. ACCORDING TO THE REPORTER, THE SURGEON SEEMED TO BE OFF ANGLE WHEN TRYING TO ENGAGE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITH OTHER LIKE DEVICES IN THE SAME BONE HOLES. THE DEVICES ARE BEING RETURNED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8019298 ↗
• MalfunctionOct 30, 2018Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE SURGEON BENT THE BIOKNOTLESS ANCHORS DEVICES TRYING TO FIXATE THEM WITH A PATIENT DURING ROTATOR CUFF REPAIR SURGICAL PROCEDURE. ACCORDING TO THE REPORTER, THE SURGEON SEEMED TO BE OFF ANGLE WHEN TRYING TO ENGAGE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. THE CASE WAS COMPLETED WITH OTHER LIKE DEVICES IN THE SAME BONE HOLES. THE DEVICES ARE BEING RETURNED. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 8019297 ↗
• MalfunctionSep 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT FELL AND DURING THE SURGERY IT WAS DISCOVERED THAT THE BIOKNOTLESS PLUS ANCHOR THAT HAD BEEN INSERTED ON (B)(6) 2011 HAD BROKEN AND WAS FLOATING FREE IN THE JOINT SPACE. THE SURGEON RETRIEVED THE BROKEN PIECE OF ANCHOR, LEAVING THE OTHER HALF SECURELY IN THE BONE. THE SURGEON COMPLETED THE PROCEDURE USING 2 OR 3 ADDITIONAL ANCHORS TO REPAIR THE NEW TEAR WITH NO PATIENT CONSEQUENCES OR DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7867410 ↗
• MalfunctionJul 25, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE DISTAL TIP OF THE CUSTOMER'S BIOKNOTLESS PLUS ANCHORS WITH ORTHOCORD BROKE UPON INSERTION INTO THE BONE HOLE DURING A SHOULDER PROCEDURE. THE SURGEON REMOVED THE ANCHOR AND ALL BROKEN PIECES AND UPON INSERTION OF THE SECOND ANCHOR, WHICH WAS THE EXACT SAME ANCHOR, THE DISTAL TIP OF THE SECOND ANCHOR ALSO BROKE UPON INSERTION. THE SURGEON REMOVED ALL BROKEN PIECES OF THE SECOND ANCHOR AND USED A THIRD ONE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THE FINAL ANCHOR WAS THE SAME EXACT ANCHOR. THE CASE WAS DELAYED BY 10 MINUTES. BOTH BROKEN ANCHORS WERE ALREADY DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7720082 ↗
• MalfunctionJul 25, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE DISTAL TIP OF THE CUSTOMER'S BIOKNOTLESS PLUS ANCHORS WITH ORTHOCORD BROKE UPON INSERTION INTO THE BONE HOLE DURING A SHOULDER PROCEDURE. THE SURGEON REMOVED THE ANCHOR AND ALL BROKEN PIECES AND UPON INSERTION OF THE SECOND ANCHOR, WHICH WAS THE EXACT SAME ANCHOR, THE DISTAL TIP OF THE SECOND ANCHOR ALSO BROKE UPON INSERTION. THE SURGEON REMOVED ALL BROKEN PIECES OF THE SECOND ANCHOR AND USED A THIRD ONE TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES. THE FINAL ANCHOR WAS THE SAME EXACT ANCHOR. THE CASE WAS DELAYED BY 10 MINUTES. BOTH BROKEN ANCHORS WERE ALREADY DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO 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 Consequences Or Impact To Patient

  MAUDE report 7720064 ↗
• MalfunctionJul 24, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A SHOULDER PROCEDURE, FOUR (4) OF THE CUSTOMER'S BIOKNOTLESS PLUS W/ORTHO ANCHORS BROKE DURING INSERTION. NOTHING WAS LEFT IN THE PATIENT. THEY OPENED A FIFTH ANCHOR PACKAGE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICES. THE SALES REPRESENTATIVE STATED HE WAS NOT PRESENT. PLEASE SEE ALSO MEDWATCH REPORTS 1221934-2018-52325, 1221934-2018-52324 AND 1221934-2018-52323.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713599 ↗
• MalfunctionJul 24, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A SHOULDER PROCEDURE, FOUR (4) OF THE CUSTOMER'S BIO KNOTLESS PLUS W/ORTHO ANCHORS BROKE DURING INSERTION. NOTHING WAS LEFT IN THE PATIENT. THEY OPENED A FIFTH ANCHOR PACKAGE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICES. THE SALES REPRESENTATIVE STATED HE WAS NOT PRESENT. PLEASE SEE ALSO MEDWATCH REPORTS: 1221934-2018-52325, 1221934-2018-52324 AND 1221934-2018-52322.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713597 ↗
• MalfunctionJul 24, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A SHOULDER PROCEDURE, FOUR (4) OF THE CUSTOMER'S BIO KNOTLESS PLUS W/ORTHO ANCHORS BROKE DURING INSERTION. NOTHING WAS LEFT IN THE PATIENT. THEY OPENED A FIFTH ANCHOR PACKAGE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICES. THE SALES REPRESENTATIVE STATED HE WAS NOT PRESENT. PLEASE SEE ALSO MEDWATCH REPORTS: 1221934-2018-52325, 1221934-2018-52323 AND 1221934-2018-52322.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713589 ↗
• MalfunctionJul 24, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A SHOULDER PROCEDURE, FOUR (4) OF THE CUSTOMER'S BIO KNOTLESS PLUS W/ORTHO ANCHORS BROKE DURING INSERTION. NOTHING WAS LEFT IN THE PATIENT. THEY OPENED A FIFTH ANCHOR PACKAGE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICES. THE SALES REPRESENTATIVE STATED HE WAS NOT PRESENT. PLEASE SEE ALSO MEDWATCH REPORTS: 1221934-2018-52324, 1221934-2018-52323 AND 1221934-2018-52322.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713575 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062170, K150209. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-0316-2012 · Oct 31, 2011 · Terminated
  DePuy Mitek Lupine Loop Plus w/ Orthocord DS Catalog #210709 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate pos
• Z-0315-2012 · Oct 31, 2011 · Terminated
  DePuy Mitek Lupine Loop Plus w/ Orthocord Catalog #210708 The LUPINE BR Anchor System is indicated for use in soft tissue to bone fixation in association with adequate posto