LUPINE PANACRYL 210707Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886705001057), received between Jan 16, 2019 and Jan 16, 2019 — classified as 1 malfunction.

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

7 other recalls cover devices cleared under the same FDA submission (K062170); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2019Material Frayed; Material Frayed

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A SHOULDER INSTABILITY SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SUTURE BROKE WHILE TENSIONING. ACCORDING TO THE REPORTER, THE THREAD WAS RIPPED IN THE KNOT WHILE THE ANCHOR WAS STILL IMPLANTED IN THE PATIENT. IT WAS FURTHER REPORTED THAT THE ANCHOR BROKE BUT IT HAS BEEN REMOVED COMPLETELY AND NOTHING WAS LEFT IN THE PATIENT. IT WAS REPORTED THAT IT MIGHT HAVE DUE TO THE SURGEON BEING OFF-AXIS. IT WAS REPORTED THAT THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A DELAY OF NOT MORE THAN FIVE MINUTES. 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 8253856 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K062170. 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-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-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