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Cancellous Screw, Locking 37302-16Recalls & reported problems

I.T.S. GmbH · Cancellous Screw, Locking, D=3.0mm, L=16mm · Class 2 · Implant

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

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 09120034301643), received between Jan 8, 2019 and Jan 8, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K033756); 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

  • Insufficient Device Problem Information1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJan 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT 2 LOCKING CANCELLOUS SCREWS D=3.0MM GOT LOOSE IN THE MOST DISTAL HOLE ROW OF A PROLOCK RADIUS PLATE. THIS IS REPORT IS 2 OF 3.

    Patient problems: No Information

    MAUDE report 8226317 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033756. One submission often covers many models, so check the product and lot details in each record.

  • Z-1592-2026 · Jan 23, 2026 · Open, Classified
    Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II. Article Numbers: 21031-3, 21031-5, 21032-11, 21032-3, 21032-5, 21033-3, 21033-5,

Other Screw, Fixation, Bone devices

All Screw, Fixation, Bone devices →

Sources and updates

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