# FDA recall Z-0570-2021

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2020-11-17.

## Product

Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal System, 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0570-2021
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-17
- **Report date:** 2020-12-23
- **Termination date:** 2021-07-27

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0570-2021

## Citation

> AI Analytics. FDA recall Z-0570-2021. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-0570-2021. Source: US FDA. Licensed CC0.

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