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Cortical Screw 32151-11Recalls & reported problems

I.T.S. GmbH · Cortical Screw, D=1.5mm, L=11mm · 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 09120047305348), received between Mar 2, 2020 and Mar 2, 2020 — 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 (K142418); 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.

  • MalfunctionMar 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

    IT WAS REPORTED THAT THE SCREW HEAD OF A NON-LOCKING SCREW SCREW BROKE OFF. PRODUCT WAS USED FOR 4TH METACARPAL FIXATION.

    Patient problems: No Information

    MAUDE report 9773424 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142418. One submission often covers many models, so check the product and lot details in each record.

  • Z-1607-2026 · Jan 23, 2026 · Open, Classified
    HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1. Cortical Screw; Article Numbers: 32151-6, 32151-8, 32151-9, 32151-10, 32151-11,

Other Screw, Fixation, Bone devices

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Sources and updates

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