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INTRAFIX 254602Recalls & reported problems

Depuy Mitek, LLC · INTRAFIX Tapered Screw 6-8mm x 30mm · Class 2 · Implant

All models of INTRAFIX (14)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705013081), received between Jun 22, 2018 and Jul 12, 2022 — classified as 1 injury, 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Break1

Patient problems

  • No Consequences Or Impact To Patient1
  • Unspecified Tissue Injury1

Recent adverse event reports

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

  • 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 (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE INTRAFIX 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 14990096 ↗
  • MalfunctionJun 22, 2018Break; Break

    THE SALES REP REPORTED THAT WHILE GOING THROUGH HIS INVENTORY A LARGER PIECE OF HARDWARE FELL ON A COUPLE OF HIS INTRAFIX TAPERED SCREWS BREAKING THEM. THE SALES REP CONFIRMED THEY WERE NOT USED IN A PROCEDURE AND THERE WERE NO PATIENT CONSEQUENCES. THE DEVICES WERE DISCARDED. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-50829.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7631088 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150209, K983560. 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-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
  • 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

Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page