# FDA recall Z-1409-2023

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2023-02-16.

## Product

INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size:  4.0mm x 24mm, REF 3604024; for immobilization and stabilization of spinal segment as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7), and the thoracic spine from T1-T3.

## Reason for recall

Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-1409-2023
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-16
- **Report date:** 2023-04-26

- **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-1409-2023

## Citation

> AI Analytics. FDA recall Z-1409-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1409-2023. Source: US FDA. Licensed CC0.

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