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Restrictor B000-1185Recalls & reported problems

Howmedica Osteonics Corp. · Universal Cement Restrictor - Disposable Inserter · Class 2 · Implant

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 07613153768258), received between Dec 18, 2018 and Dec 18, 2018 — classified as 1 malfunction.

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

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionDec 18, 2018Break; Break

    THE CLINIC REPORTED TO THE CUSTOMER SERVICE THE FOLLOWING EVENT: "THE SHUTTER PLUG BROKE DURING USE, ON THE PATIENT".

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8174312 ↗

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

All Prosthesis, hip, semi-constrained, metal/polymer, cemented devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.