BIOKNOTLESS PANACRYL ETHIBOND 212725Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705002115), received between Jul 24, 2018 and Jul 24, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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-1678-2023 · Root cause: Use error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2018Break; Break

  THE SURGEON WAS DOING A BANKART REPAIR AND WHEN TRYING TO INSERT THE TIP OF THE ANCHOR INTO THE HOLE ONE SIDE OF THE TIP BROKE OFF. RETRIEVED THE PIECE OF THE ANCHOR THAT BROKE. OPENED A NEW ANCHOR AND COMPLETED THE CASE WITH NO PROBLEMS. THE PATIENT, A FEMALE ESTIMATED TO BE IN HER UPPER 20'S TO EARLY 30'S, HAD AVERAGE BONE QUALITY. THE PATIENT HAD OTHER SURGERIES IN HER PAST, A PRIOR SHOULDER SCOPE THAT DID NOT INVOLVE ANY ANCHORS, AND A BACK SURGERY. THIS SURGERY REMAINED ARTHROSCOPIC AFTER THE COMPLAINT DEVICE BROKE. THE PROCEDURE WAS EXTENDED 3 TO 5 MINUTES DUE TO THE ANCHOR BREAKING. THE COMPLAINT DEVICE WAS REMOVED AND DISCARDED. THE SALES REP STATED THAT SHE BELIEVES THE SURGEON WAS OFF AXIS DURING INSERTION AT THE TIME THE TIP OF THE ANCHOR BROKE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7715145 ↗

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-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-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-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