Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1019-2016 — Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).

U.S. FDA — Device Enforcement · United States · 2016-02-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1019-2016
Date of alert
2016-02-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Zimmer Spine, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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