Zimmer Biomet, Inc.: Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Recall number

Z-0570-2021

Recalling firm

Zimmer Biomet, Inc.

Product

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system

Status

Terminated

Initiated

2020-11-17

Posted

not on file

Terminated

2021-07-27

Reason

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.

Root 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

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.

Lot, serial or model codes

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.

510(k) numbers

["K140123"]

PMA numbers

not on file

Product code

NKB

Firm FEI

1000220733

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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