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Recall Observatory FDA recall evidence

Device product

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

Z-1019-2016

February 03, 2016

Class II

Product summary

Firm
Zimmer Spine, Inc.
Event
Event 73265
Status
Terminated
Classification
Class II
Quantity
15,753
Official record key
device-enforcement:Z-1019-2016

Official wording

Reason: 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.

Code information: Surgical Technique Manual L1637 Rev B (2014-06)

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.