# FDA recall Z-1574-2023

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2021-11-19.

## Product

Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal surgery

## Reason for recall

Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.

## Distribution

US:  IN, CT, NE

## Key facts

- **Recall number:** Z-1574-2023
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-11-19
- **Report date:** 2023-05-17

- **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-1574-2023

## Citation

> AI Analytics. FDA recall Z-1574-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1574-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*