# FDA recall Z-0352-2018

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2017-12-06.

## Product

Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R

## Reason for recall

Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.

## Distribution

US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US

## Key facts

- **Recall number:** Z-0352-2018
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-12-06
- **Report date:** 2018-01-24
- **Termination date:** 2019-11-04

- **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-0352-2018

## Citation

> AI Analytics. FDA recall Z-0352-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0352-2018. Source: US FDA. Licensed CC0.

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