PANALOK ETHIBOND 210025Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705000807), received between May 29, 2020 and Oct 23, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED FROM JAPAN THAT DURING A BANKART SHOULDER REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT WHEN ATTEMPTING TO INSERT THE PANALOK ABSORBABLE ANCHOR 3.5MM INTO THE BONE, THE SHOULDER LOOSENED, AND THE ANCHOR COULD NOT BE PLACED IN THE BONE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20514963 ↗
• MalfunctionJul 2, 2024Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY THE SALES REP IN JAPAN THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6)2024, WHEN THE PANALOK #2 ETHIBOND GREEN CP-2 DEVICE WAS INSERTED AFTER DRILLING, IT DID NOT GO IN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PIECES IN THE PATIENT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19653276 ↗
• InjuryMay 29, 2020Break; Migration or Expulsion of Device; Break; Migration or Expulsion of Device

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT DURING A SHOULDER REPAIR, A PANALOK #2 ETHIBOND GREEN CP-2 AND A PANALOK #2 ETHIBOND WHITE CP-2 EA, PRESENTED ISSUES. WHEN PLACING PANALOK HAD ONE ANCHOR PULL OUT AFTER INSERTION (STILL ATTACHED TO HANDLE). ON THE OTHER PANALOK ANCHOR, THE ANCHOR WAS INSERTED BUT THE METAL TIP OF THE INSERTER WAS BROKEN OFF. ONCE THEY NOTICED THE TIP WAS BROKEN THEY SPENT APPROXIMATELY 1 HOUR LOOKING FOR THE METAL PIECE. BROUGHT IN X-RAY TO CONFIRM THAT METAL TIP WAS IN SHOULDER BUT COULD NOT LOCATE. PROCEDURE WAS COMPLETED SUCCESSFULLY BUT THERE WAS A SURGICAL DELAY OF 60 MINUTES. NO PATIENT CONSEQUENCES REPORTED. DEVICES WERE DISCARDED.

  Patient problems: Foreign Body In Patient; Not Applicable

  MAUDE report 10101573 ↗

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-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-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-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