# FDA recall Z-0448-2022

> **Flower Orthopedics Corporation** · Class II · device recall initiated 2021-11-02.

## Product

Flex-Thread Inserter Shaft intended for  Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System-  Catalog Number: 8435-1

## Reason for recall

Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available

## Distribution

US Nationwide distribution in the states of AZ, CA, CO, GA, TN, FL, IL, MA, MD, NC, TX.

## Key facts

- **Recall number:** Z-0448-2022
- **Recalling firm:** Flower Orthopedics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-11-02
- **Report date:** 2022-01-12
- **Termination date:** 2023-10-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Horsham, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0448-2022

## Citation

> AI Analytics. FDA recall Z-0448-2022. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0448-2022. Source: US FDA. Licensed CC0.

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