INTRAFIX 254685Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705013661), received between Oct 30, 2018 and Nov 25, 2024 — classified as 2 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K063577, 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 16, 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 25, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT WHEN USING THE INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM 10MM DEVICE, AFTER DRILLING THE FEMORAL TUNNEL AND INSERTING THE SHEATH, THE SHEATH CRUMPLED INTO THE JOINT AND WAS DAMAGED. ACCORDING TO THE REPORTER, THE DOCTOR HAD TO REMOVE THE SHEATH BEFORE INSERTING THE SCREW. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 20773872 ↗
• MalfunctionOct 30, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM 9MM DEVICES BACKED OUT OF THE TUNNEL WHEN THE SCREW WAS BEING SCREWED IN. THEY THEN USED THE SALES REP'S INTRAFIX FEMORAL SHEATH AND SCREW SYSTEM 10MM, WHICH ALSO BACKED OUT OF THE TUNNEL WHILE THE SCREW WAS BEING SCREWED IN. EACH DEVICE WAS REMOVED FROM THE PATIENT WITH NO DEBRIS LEFT BEHIND. THE SALES REP STATED THAT THE PATIENT'S BONE QUALITY WAS NORMAL. THE CASE WAS COMPLETED WITH A RIGIDFIX DEVICE IN THE SAME BONE HOLE WITH NO PATIENT HARM OR DELAY. THE DEVICES WERE DISCARDED BY THE CUSTOMER. 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 8020526 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063577, 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-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-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-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