Reported Mar 9, 2016 · Terminated

Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

Zimmer Spine, 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 Spine, Inc. · 7375 Bush Lake Rd · Minneapolis, MN · 55439-2027

Is this the product you have?

  • Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Lot codes and dates
  • Surgical Technique Manual L1637 Rev B (2014-06)
Amount recalled
15,753

Where it was sold

  • Nationwide

Why it was recalled

Zimmer Biomet Spine is initiating a Medical Device Correction regarding the Virage OCT Spinal Fixation System by providing additional guidance in the Virage OCT Surgical Technique Manual.

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 Oct 11, 2016 · Data as of Sep 19, 5:59 PM UTC

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