Skip to content

Instinct™ Java® System 046W0AN65545Recalls & reported problems

Zimmer Spine · Class 2

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 00889024341739), received between Jan 20, 2021 and Jan 20, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (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

  • Material Twisted/Bent1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJan 20, 2021Material Twisted/Bent; Material Twisted/Bent

    IT WAS REPORTED THAT THE THREADED SHAFTS OF TWO REDUCTION SCREWS WERE FOUND BENT VIA X-RAYS DURING SURGERY AFTER BEING INSTALLED. THE SCREWS WERE REMOVED, AND ARE ASSUMED TO HAVE BEEN REPLACED WITHOUT REPORTED PATIENT IMPACTS. THIS IS REPORT ONE OF TWO FOR THIS EVENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 11202540 ↗

Other Orthosis, spondylolisthesis spinal fixation devices

All Orthosis, spondylolisthesis spinal fixation devices →

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