Reported Jan 20, 2016 · Terminated

Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304

Is this the product you have?

  • Zimmer, Virage OCT Spinal Fixation System
  • Item Number07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Lot codes and dates
  • Lots
    • 62968065
    • 62947660
    • 62536230
    • 62745662
    • 62773482
    • 62758613
    • 62874869
Amount recalled
372

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Why it was recalled

Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 12, 2016 · Data as of Sep 19, 6:01 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.