# FDA recall Z-2603-2018

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2018-07-09.

## Product

Medtronic CD HORIZON Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, or sacral spine.MULTI-AXIAL SCREW FOR 5.5/6.0MM RODS, REF 55840005045

## Reason for recall

This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw.  The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm diameter screw when the actual screw diameter aligns with 5.0 diameter screw size requirements.

## Distribution

US

## Key facts

- **Recall number:** Z-2603-2018
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-09
- **Report date:** 2018-08-15
- **Termination date:** 2021-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Memphis, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2603-2018

## Citation

> AI Analytics. FDA recall Z-2603-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2603-2018. Source: US FDA. Licensed CC0.

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