Z-1019-2016 Class II Terminated
FDA device recall Z-1019-2016 was initiated by Zimmer Spine, Inc. on February 3, 2016 and is designated Class II. 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. The recall status is terminated (terminated October 11, 2016). Affected quantity: 15,753.
Recall Details
- Product Type
- Devices
- Report Date
- March 9, 2016
- Initiation Date
- February 3, 2016
- Termination Date
- October 11, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15,753
Product Description
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
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.
Distribution Pattern
Distributed US (nationwide) and in the countries of Australia and Germany.
Code Information
Surgical Technique Manual L1637 Rev B (2014-06)