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Zimmer Spine, Inc. recalls Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Recalled March 9, 2016 · FDA recall Z-1019-2016 · Zimmer Spine
Hazard
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. · FDA Class II
Units
15,753
Sold at
Distributed US (nationwide) and in the countries of Australia and Germany.
Description
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.
Product
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Manufacturer(s)
Zimmer Spine, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →