Class 2 Device Recall Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System

• Date Initiated by Firm: November 17, 2020
• Create Date: December 15, 2020
• Recall Status: Terminated on July 27, 2021
• Recall Number: Z-0570-2021
• Recall Event ID: 86762
• 510(K)Number: K140123
• Product Classification: Thoracolumbosacral pedicle screw system - Product Code NKB
• Product: Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
• Code Information: There have been 756 item numbers cleared in the US that are included in the recall scope, as listed on the first tab of the attached ZFA 2020-00333 Affected Product List. To date, there have only been products manufactured for a portion of the affected item numbers. In addition, there are three kit part numbers affected as well. The lot specific information is included on the second tab of the attached ZFA 2020- 0333 Affected Product List.
• Recalling Firm/ Manufacturer: Zimmer Biomet, Inc.; 1800 W Center St; Warsaw IN 46580-2304
• For Additional Information Contact: Customer Service; 800-447-3625
• Manufacturer Reason for Recall: Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal System Translation Screw and Cypher MIS Screw System. Users should be aware that changes were made to the contraindications section indicating that the Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system.
• FDA Determined Cause: Use error
• Action: On November 17, 2020, the firm distributed Urgent Medical Device Correction letters to customers. Customers were notified that changes were made to the contraindications section indicating the following: "Translation Screws should not be used with a direct current stimulation, as a high probability of construct failure exists when using Translation Screws containing CoCr with direct current simulation system." The updated instruction for use is available electronically at labeling.zimmerbiomet.com, and the updated surgical technique is available electronically at zimmerbiomet.com. Customers were asked to do the following: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Ensure that the most updated instructions for use (IFU) (060505-02  Polaris Spinal System IFU and 14-501697-00  Cypher MIS Screw System IFU) and the surgical techniques (0744.1-US-en-REV1120 Polaris 5.5 Spinal System Surgical Technique Guide, 0746.1-US-en-REV1120 Polaris Spinal System Translation Screw Surgical Technique Guide, and 2075.1-US-en-REV1120 Cypher MIS Screw System Surgical Technique Guide) for the Polaris Spinal System Translation Screw and Cypher MIS Screw Systems are used, effective immediately, for surgeries that require the affected items. a. Access the instruction for use at labeling.zimmerbiomet.com by navigating to key-code 060505-02 and 14-501697-00. b. Access the surgical technique at zimmerbiomet.com by navigating to https://www.zimmerbiomet.com/medical-professionals/spine/product/polaris-5-5-spinal-system.html and https://www.zimmerbiomet.com/medical-professionals/spine/product/cypher-mis-screw-system.html. c. Destroy any previous copies of the instruction for use and surgical technique. Customers are to complete and return the Acknowledgement Form accompanying the notification. If you have further questions or concerns about this recall, please call Zimmer Biomet's customer service at 800-447-3625 betwee
• Quantity in Commerce: 57,715 units
• Distribution: Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NKB