Zimmer Biomet, Inc. Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Brand
Zimmer Biomet, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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.
Zimmer Biomet, Inc. is recalling Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw sys due to Zimmer Biomet is conducting a medical device correction to update the Instructions for Use (IFU) and the Surgical Techniques for the Polaris Spinal Sy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026