ORTHOCORD HEALIX BR 222239Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705007851), received between Nov 9, 2018 and Nov 9, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K073412, 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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 9, 2018Break; Break

  IT WAS REPORTED THAT TWO ANCHORS BROKE DURING A PROCEDURE. AT THE END OF SCREWING ANCHOR IN THE LEFT CALCANEUS OF THE PATIENT, IT BROKE AT THE DISTAL PART (HEAD ANCHOR). THE DEBRIS THAT FELL INTO THE PATIENT WAS REMOVED. NO CONSEQUENCES TO THE PATIENT; ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52745.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055448 ↗
• MalfunctionNov 9, 2018Break; Break

  IT WAS REPORTED THAT TWO ANCHORS BROKE DURING A PROCEDURE. AT THE END OF SCREWING ANCHOR IN THE LEFT CALCANEUS OF THE PATIENT, IT BROKE AT THE DISTAL PART (HEAD ANCHOR). THE DEBRIS THAT FELL INTO THE PATIENT WAS REMOVED. NO CONSEQUENCES TO THE PATIENT; ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-52744.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8055276 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K073412, K150209. 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-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-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-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-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-2208-2011 · Feb 24, 2011 · Terminated
  DePuy Mitek GRYPHON T BR DS Anchor w/ORTHOCORD Product Code: 210811 Gryphon BR Suture Anchors are intended for: Shoulder: Rotor Cuff Repair, Bankart Repair, SLAP Lesion Repair, Bic