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Instinct™ Java® System 046W0AN46540Recalls & 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 00889024341081), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 Deformation1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionOct 21, 2021Material Deformation; Material Deformation

    IT WAS REPORTED THAT DURING THE SURGERY, A CLOSURE TOP AND A SCREW STRIPPED INTRA-OPERATIVELY. ALSO, A SECOND CLOSURE TOP STRIPPED ON THE SAME SCREW. ALL PIECES WERE REMOVED AND REPLACED WITH ALTERNATIVES TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED PATIENT IMPACTS. THIS IS REPORT THREE OF THREE FOR THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12672113 ↗

Other Orthosis, spinal pedicle fixation, for degenerative disc disease devices

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