# FDA recall Z-1506-2020

> **TeDan Surgical Innovations LLC** · Class II · device recall initiated 2019-02-18.

## Product

DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: These products are intended to be used by trained surgeons and are designed for use with TSI distractors and screwdrivers.

## Reason for recall

The items identified for recall are labeled as sterile. However, the manufacturer has found that product packaging for the lots listed above may be damaged, potentially exposing the product to non sterile conditions. This situation presents a risk of infection to patients.

## Distribution

Worldwide.

## Key facts

- **Recall number:** Z-1506-2020
- **Recalling firm:** TeDan Surgical Innovations LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-18
- **Report date:** 2020-03-25
- **Termination date:** 2021-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sugar Land, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1506-2020

## Citation

> AI Analytics. FDA recall Z-1506-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1506-2020. Source: US FDA. Licensed CC0.

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