# FDA recall Z-0034-2022

> **Flower Orthopedics Corporation** · Class II · device recall initiated 2021-09-03.

## Product

Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

## Reason for recall

Product kit missing CDG 200 (Cannulated Countersink for 3.0-4.5mm Screws) from EWK 201 (Flower E-Kit, Advanced)

## Distribution

US Nationwide distribution in the states of AZ, CA, CO,CT, FL, IL,  IN,  NC, NY, NV, OH, WV, TX.

## Key facts

- **Recall number:** Z-0034-2022
- **Recalling firm:** Flower Orthopedics Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-09-03
- **Report date:** 2021-10-13
- **Termination date:** 2022-07-28

- **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-0034-2022

## Citation

> AI Analytics. FDA recall Z-0034-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0034-2022. Source: US FDA. Licensed CC0.

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