Recall Z-0625-2016
Zimmer Biomet, Inc. · initiated November 17, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Zimmer, Virage OCT Spinal Fixation System, Item Number: 07.01738.001, a posterior system intended to achieve an implant and construct of the Occipital-Cervical-Thoracic spine (Occiput-T3). UDI Number 889024328952
Codes / lots: Lots: 62968065, 62947660, 62536230, 62745662, 62773482, 62758613, 62874869
Reason for recall
Zimmer Biomet is initiating a recall of the Virage Occipital Eyelet, as it was found through product testing that the staking of the set screw was out of specification and can interfere with the insertion of the occipital rod when the set screw is staked too low.
FDA-determined cause: Process control
Action taken
Consignees were sent a Zimmer Biomet "Urgent Medical Device Recall" letter dated November 17, 2015. One letter was addressed to Risk Manager and Surgeons and a separate letter was sent to Distributors, Sales Representatives, and Distributor Operations Mangers. The letters described the problem and the product involved in the recall. The letter described the "Risk" and the responsibilities of consignees and requested consignees to quarantine the product. Risk Managers and Surgeons were requested to complete and return the Certificate of Acknowledgment form. Distributors, Sales Representatives, and Distributor Operations Mangers were requested to complete and return the Inventory Return certification Form. For questions consignees can call the customer call center at 1-866-774-6368 between 8:00 am and 5:00 pm EST.
Details
- Recall number
- Z-0625-2016
- Initiated
- November 17, 2015
- Terminated
- August 12, 2016
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 372
- Distribution
- US: AL, AZ, CA, CO, FL, GA, ID, MI, MN, MO, NV, NJ, OK, OR, PA, SD, TN, TX, WA, WI. OUS: AUSTRALIA, GERMANY, SWITZERLAND, SWEDEN.
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN