Recall Z-1019-2016
Zimmer Spine, Inc. · initiated February 3, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Virage OCT Spinal Fixation System. Intended to promote fusion of the Occipital-Cervical-Thoracic spine (Occiput-T3).
Codes / lots: Surgical Technique Manual L1637 Rev B (2014-06)
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.
FDA-determined cause: Under Investigation by firm
Action taken
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 corporatequality.postmarket@zimmerbiomet.com. Questions or concerns can be directed to Customer Service at 1-866-774-6368
Details
- Recall number
- Z-1019-2016
- Initiated
- February 3, 2016
- Terminated
- October 11, 2016
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 15,753
- Distribution
- Distributed US (nationwide) and in the countries of Australia and Germany.
- Recalling firm
- Zimmer Spine, Inc., Minneapolis, MN