INTRAFIX 254652Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886705022380), received between Dec 20, 2017 and Jul 23, 2025 — classified as 3 injuries, 2 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K013572, K122123, K150209, K983560); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 6 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER DUA-SPORTS-2024-017 CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX PEEK TPR SCR, 6-8MMX30MM DEVICE FAILED AND THE PATIENT REQUIRED A RE-OPERATION OR REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 22579295 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (B)(4) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX ® PEEK TAPERED SCREW 6-8MM X 30MM DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14991071 ↗
• MalfunctionDec 29, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2020, IT WAS OBSERVED THAT THE THREADS OF THE INTRAFIX ® PEEK TAPERED SCREW 6-8MM X 30MM DEVICE WERE KNOTTED AS INSERTED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHOUT DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11086587 ↗
• MalfunctionMay 21, 2018Separation Failure; Separation Failure

  IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING AN ACL PROCEDURE, THE DOCTOR INSERTED THE INTRAFIX TIBIAL SHEATH FINE, BUT WHEN HE WAS TRYING TO INSERT THE INTRAFIX PEEK SCREW, IT WOULD NOT SCREW IN THE BONE. THE DOCTOR STATED THE SHEATH WAS GETTING DAMAGED DUE TO THE PATIENT'S HARD BONE, AND REMOVED THE SHEATH. THE DOCTOR ATTEMPTED TO INSERT ANOTHER SHEATH AND SCREW, BUT THE SAME THING HAPPENED. THE DOCTOR THEN RE-DILATED THE HOLE AND USING THE SAME SIZE SHEATH AND SCREW SUCCESSFULLY COMPLETED THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES OR DELAYS. NO REPLACEMENT DEVICES WERE SENT OUT, JUST A TRUNK ADJUSTMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7530208 ↗
• InjuryDec 20, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT EXPERIENCED A FRACTURED TIBIAL PLATEAU TWO MONTHS AFTER AN ACL PROCEDURE DUE TO THE INTRAFIX TIBIAL SHEATH TRIAL/T-HANDLE MIGRATING INTO THE JOINT SURFACE. THE CASE WAS COMPLETED WITHOUT ANY ISSUES PRIOR TO THE INCIDENT. THE CUSTOMER IS REFUSING TO SEND THE DEVICE BACK. THE SALES REP PROVIDED ADDITIONAL INFORMATION VIA PHONE ON 12-11-2017 THAT THE SURGERY DATE WAS (B)(6) 2017. THE SALES REP ALSO STATED THAT IT WAS A INTRAFIX PEEK TAPER SCREW, 6-8 MM X 30 MM THAT HAD MIGRATED UP THE TIBIAL PLATEAU IN THE PATIENT. THE SCREW WAS NOT REMOVED BUT IT WAS BROUGHT BACK DOWN WITH ANOTHER SCREW AND SUTURE.

  Patient problems: Tissue Damage

  MAUDE report 7137042 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013572, K122123, K150209, K983560. 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-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-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