Z-0570-2021Class II

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

Name: Z-0570-2021 Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Creator: Zimmer Biomet, Inc.
Published: 2020-11-17
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-11-17 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Biomet, Inc. began a recall of Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system on 2020-11-17. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0570-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-17
Posted: 2020-12-15
Terminated: 2021-07-27
Recalling firm: Zimmer GmbH
Product: Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: labeling and UDI
FDA 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 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0570-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0570-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-23	2020-12-15

Product code NKB

K140123Class IIPolaris Spinal System -Translation ScrewEbi, LLC / cleared 2014-04-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)