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Terminated

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

FDA Recall Z-1019-2016 · Posted None

Recalling FirmZimmer Spine, Inc.
Recall StatusTerminated
Product CodeKWP
Date Initiated2016-02-03
Date Terminated2016-10-11
Product Quantity15,753

Reason for Recall

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.

Firm Action

Distributors, Hospital Risk Managers and Surgeons were notified via an Urgent Medical Device Correction letter beginning 2/3/2016. The letter identified affected product, described the issue and listed their responsibilities. A Certificate of Acknowledgement form was asked to be returned to Zimmer Biomet via email to [email protected]. Questions or concerns can be directed to Customer Service at 1-866-774-6368

Root Cause

Under Investigation by firm

Distribution Pattern

Distributed US (nationwide) and in the countries of Australia and Germany.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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