# FDA recall Z-0086-2022

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2021-09-02.

## Product

Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm

## Reason for recall

Engraving on implants may not match what is listed on the pouch labels.

## Distribution

Distribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WV

## Key facts

- **Recall number:** Z-0086-2022
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-02
- **Report date:** 2021-10-20
- **Termination date:** 2023-10-05

- **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-0086-2022

## Citation

> AI Analytics. FDA recall Z-0086-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0086-2022. Source: US FDA. Licensed CC0.

---

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