FDA-Device2020-12-23Class II
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Zimmer Biomet, Inc.
Hazard
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.
Sold states
Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.
Affected count
57,715 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, Thoracolumbosacral pedicle screw system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2021Don't want to check this manually?
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