PANALOK PANACRYL 210725Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886705001156), received between Nov 8, 2018 and Dec 14, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

5 other recalls cover devices cleared under the same FDA submission (K150209, K952687); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT DURING AN ARTHROSCOPIC SUPRASPINATUS REPAIR PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE PANALOK #2 PAN CP-2 DEVICE COULD NOT BE FIRED AS IT WAS BLOCKED DURING OPERATION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003000 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THREE ANCHORS WERE BEING USED FOR A SUTURE ON THE ELBOW TENDON. IT WAS REPORTED THAT A HOLE FOR THE ANCHOR WAS DONE WITH THE BROACH. ACCORDING TO THE REPORTER. THE IT WAS OBSERVED THAT THE FIRST ANCHOR WAS CAUGHT ON THE INTRODUCER AND WAS IMPOSSIBLE TO USE. IT WAS REPORTED THAT THE TWO OTHER ANCHORS WITH THE SAME LOT NUMBER WERE USED WITHOUT SUCCESS. A FOURTH ANCHOR WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THE SURGEON HAD TO MODIFY THE SURGICAL TECHNIQUE BY MULTIPLYING THE APPROXIMATION SUTURES INSTEAD OF THE ANCHOR. IT WAS REPORTED THAT A SECOND HOLE WAS MADE BUT WEAKENING THE SIDE. THERE WAS A SURGICAL DELAY OF A FEW UNSPECIFIED MINUTES. IT WAS REPORTED THAT THE PATIENT IS AN ACTIVE SMOKER. IT WAS REPORTED THAT THE STATUS OF THE PATIENT POST-SURGERY WAS WELL. IT WAS REPORTED THAT THE FINAL RESULT WILL BE SEEN AT THE MOBILIZATION AND DURING THE REMOVAL OF THE RESIN IN A FEW WEEKS. IT WAS REPORTED THAT THERE WAS NO INCIDENT AT THE END OF THE INTERVENTION BUT WAS NOT SPECIFIED THE TYPE OF INTERVENTION. IT WAS NOT REPORTED IF THERE WAS A PROLONGED HOSPITALI

  Patient problems: Injury

  MAUDE report 8203943 ↗
• InjuryDec 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THREE ANCHORS WERE BEING USED FOR A SUTURE ON THE ELBOW TENDON. IT WAS REPORTED THAT A HOLE FOR THE ANCHOR WAS DONE WITH THE BROACH. ACCORDING TO THE REPORTER. THE IT WAS OBSERVED THAT THE FIRST ANCHOR WAS CAUGHT ON THE INTRODUCER AND WAS IMPOSSIBLE TO USE. IT WAS REPORTED THAT THE TWO OTHER ANCHORS WITH THE SAME LOT NUMBER WERE USED WITHOUT SUCCESS. A FOURTH ANCHOR WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THE SURGEON HAD TO MODIFY THE SURGICAL TECHNIQUE BY MULTIPLYING THE APPROXIMATION SUTURES INSTEAD OF THE ANCHOR. IT WAS REPORTED THAT A SECOND HOLE WAS MADE BUT WEAKENING THE SIDE. THERE WAS A SURGICAL DELAY OF A FEW UNSPECIFIED MINUTES. IT WAS REPORTED THAT THE PATIENT IS AN ACTIVE SMOKER. IT WAS REPORTED THAT THE STATUS OF THE PATIENT POST-SURGERY WAS WELL. IT WAS REPORTED THAT THE FINAL RESULT WILL BE SEEN AT THE MOBILIZATION AND DURING THE REMOVAL OF THE RESIN IN A FEW WEEKS. IT WAS REPORTED THAT THERE WAS NO INCIDENT AT THE END OF THE INTERVENTION BUT WAS NOT SPECIFIED THE TYPE OF INTERVENTION. IT WAS NOT REPORTED IF THERE WAS A PROLONGED HOSPITALI

  Patient problems: Injury

  MAUDE report 8203942 ↗
• InjuryNov 8, 2018Failure to Advance; Failure to Advance

  IT WAS REPORTED IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THREE ANCHORS WERE BEING USED FOR A SUTURE ON THE ELBOW TENDON. IT WAS REPORTED THAT A HOLE FOR THE ANCHOR WAS DONE WITH THE BROACH. ACCORDING TO THE REPORTER. THE IT WAS OBSERVED THAT THE FIRST ANCHOR WAS CAUGHT ON THE INTRODUCER AND WAS IMPOSSIBLE TO USE. IT WAS REPORTED THAT THE TWO OTHER ANCHORS WITH THE SAME LOT NUMBER WERE USED WITHOUT SUCCESS. A FOURTH ANCHOR WAS USED TO COMPLETE THE SURGERY. IT WAS REPORTED THAT THE SURGEON HAD TO MODIFY THE SURGICAL TECHNIQUE BY MULTIPLYING THE APPROXIMATION SUTURES INSTEAD OF THE ANCHOR. IT WAS REPORTED THAT A SECOND HOLE WAS MADE BUT WEAKENING THE SIDE. THERE WAS A SURGICAL DELAY OF A FEW UNSPECIFIED MINUTES. IT WAS REPORTED THAT THE PATIENT IS AN ACTIVE SMOKER. IT WAS REPORTED THAT THE STATUS OF THE PATIENT POST-SURGERY WAS WELL. IT WAS REPORTED THAT THE FINAL RESULT WILL BE SEEN AT THE MOBILIZATION AND DURING THE REMOVAL OF THE RESIN IN A FEW WEEKS. IT WAS REPORTED THAT THERE WAS NO INCIDENT AT THE END OF THE INTERVENTION BUT WAS NOT SPECIFIED THE TYPE OF INTERVENTION. IT WAS NOT REPORTED IF THERE WAS A PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN

  Patient problems: Injury

  MAUDE report 8050784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150209, K952687. 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-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-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