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

Recall date

November 17, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0570-2021

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Domestic distribution nationwide. As direct stimulation devices are only available in the US, this contraindication does not apply to international customers.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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