inViZia® 07.01615.002Recalls & reported problems
Zimmer Spine, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00889024325623), received between Dec 13, 2019 and Dec 13, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Packaging Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Packaging Problem2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2019Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED PACKAGES LABELED AS BEING PLATES WITH SCREWS INSIDE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THIS WAS FOUND PRIOR TO SURGERY. THIS IS REPORT TWO OF TWO.
Patient problems: No Patient Involvement
MAUDE report 9469901 ↗MalfunctionDec 13, 2019Packaging Problem; Packaging Problem
IT WAS REPORTED THAT A DISTRIBUTOR RECEIVED PACKAGES LABELED AS BEING PLATES WITH SCREWS INSIDE. THERE WAS NO REPORTED PATIENT INVOLVEMENT, THIS WAS FOUND PRIOR TO SURGERY. THIS IS REPORT ONE OF TWO.
Patient problems: No Patient Involvement
MAUDE report 9469845 ↗
Other APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY devices
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- ZEVO™ Anterior Cervical Plate System 7710015Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall1 report
- XLP 7565050Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430344Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
- ATLANTIS® Anterior Cervical Plate System 876-170Medtronic Sofamor Danek, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- XLP 7565060Nuvasive, Inc. · APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY1 recall0 reports
- Elegance® Anterior Cervical Plate 53430113Clariance · Appliance, Fixation, Spinal Intervertebral Body1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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