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BELLATEK® CSHY06Recalls & reported problems

ZimVie US Corp LLC · BELLATEK® HYBRID BAR 6 IMPLANTS · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00844868001690), received between Dec 18, 2021 and Aug 17, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 reports).

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

  • Fracture3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 17, 2023Fracture; Fracture

    IT WAS REPORTED THAT THE BAR BROKE ON THE PATIENT¿S LEFT SIDE; APPEARS TO BE IN THE RETENTION HOLE AREA.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17563618 ↗
  • MalfunctionJun 15, 2023Fracture; Fracture

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17137282 ↗
  • MalfunctionDec 18, 2021Fracture; Fracture

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13040047 ↗

Other ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices

All ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS devices →

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