# FDA recall Z-2389-2020

> **Medtronic Sofamor Danek USA Inc** · Class II · device recall initiated 2020-04-24.

## Product

Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.

## Reason for recall

Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

## Distribution

Nationwide distribution to CA, FL, IL, IN, KY, MN, MO, MT, OH, PA, TX, VA, WA.

## Key facts

- **Recall number:** Z-2389-2020
- **Recalling firm:** Medtronic Sofamor Danek USA Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-04-24
- **Report date:** 2020-06-24
- **Termination date:** 2021-03-31

- **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-2389-2020

## Citation

> AI Analytics. FDA recall Z-2389-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-2389-2020. Source: US FDA. Licensed CC0.

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