BIOKNOTLESS ETHIBOND 212724Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705002108), received between Jun 1, 2018 and Aug 16, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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-1677-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2022Migration; Migration

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF BIOKNOTLESS PLUS W/ETHIBOND DEVICE. IT WAS REPORTED THAT POSTOPERATIVELY TO A CAPSULO-LABRAL PROCEDURE OF THE RIGHT SHOULDER INITIALLY PERFORMED ON (B)(6) 2014 THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2015 DUE TO FAILED/LOOSE BIOKNOTLESS PLUS W/ETHIBOND DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD POSTOPERATIVE ABNORMAL OR PROLONGED PAIN, POSTOPERATIVE JOINT STIFFNESS AND POSTOPERATIVE ARTHROFIBROSIS, GIRD AND FAILED ANCHOR FIXATION ON (B)(6) 2015 . IT WAS FURTHER REPORTED THAT THE PATIENT HAD POSTOPERATIVE ANCHOR LOOSENING ON (B)(6) 2015 . THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15233857 ↗
• MalfunctionJul 26, 2018Break; Break

  ON DEPLOYMENT OF BOTH ANCHORS, THE SUTURE LOOP SNAPPED. CHANGED TO SAME LIKE PRODUCT TO COMPLETE SURGERY. TWO MINUTE DELAY. NO AE TO PATIENT. ADDITIONAL INFORMATION FROM THE AFFILIATE WHEN THE SURGEON PLACED TENSION ON THE LEAD SUTURE THE LOOP OF THE BIOKNOTLESS ANCHOR SNAPPED. THE SURGEON CLAIMS THAT NOT MUCH TENSION WAS PLACED AND HE SUSPECTS THE LOOP OF THE ANCHOR WAS COMPROMISED AS THE ANCHOR WAS HAMMERED INTO THE DRILL HOLE. THE SURGEON DRILLED ADDITIONAL HOLES TO ACCOMMODATE THE ADDITIONAL ANCHORS. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54213.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723262 ↗
• MalfunctionJul 26, 2018Break; Break

  ON DEPLOYMENT OF BOTH ANCHORS THE SUTURE LOOP SNAPPED. CHANGED TO SAME LIKE PRODUCT TO COMPLETE SURGERY. 2 MINUTE DELAY. NO AE TO PATIENT. ADDITIONAL INFORMATION FROM THE AFFILIATE WHEN THE SURGEON PLACED TENSION ON THE LEAD SUTURE THE LOOP OF THE BIOKNOTLESS ANCHOR SNAPPED. THE SURGEON CLAIMS THAT NOT MUCH TENSION WAS PLACED AND HE SUSPECTS THE LOOP OF THE ANCHOR WAS COMPROMISED AS THE ANCHOR WAS HAMMERED INTO THE DRILL HOLE. THE SURGEON DRILLED ADDITIONAL HOLES TO ACCOMMODATE THE ADDITIONAL ANCHORS. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-54212.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7723261 ↗
• InjuryJun 1, 2018Break; Break

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING A SHOULDER PROCEDURE, THE INSERTER TIP ON THE CUSTOMER'S BIO KNOTLESS PLUS ANCHOR BROKE OFF. THE SALES REP WAS NOT PRESENT AT THE CASE AND WAS NOT TOLD IF THE FRAGMENT WAS REMOVED. THERE WERE NO PATIENT CONSEQUENCES. THE DEVICE IS BEING RETURNED.

  Patient problems: Foreign Body In Patient; Tissue Damage

  MAUDE report 7560624 ↗

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-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-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-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-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-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
• 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