# FDA recall Z-0883-2020

> **Synthes, Inc.** · Class II · device recall initiated 2019-12-16.

## Product

2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the sterile field.

## Reason for recall

There is a possibility that the inner cap could open when the outer cap is removed or the entire inner tube remains in the outer tube.  In both instances this could prevent the screw from being removed and used causing a surgical delay. The inner tube should remain closed and retained in the outer cap when presented to the sterile field.

## Distribution

US Nationwide distribution in the states of AL and ID.

## Key facts

- **Recall number:** Z-0883-2020
- **Recalling firm:** Synthes, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-16
- **Report date:** 2020-02-05
- **Termination date:** 2020-06-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0883-2020

## Citation

> AI Analytics. FDA recall Z-0883-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-0883-2020. Source: US FDA. Licensed CC0.

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