# FDA recall Z-1429-2022

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2020-11-18.

## Product

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

## Reason for recall

Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.

## Distribution

United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.

## Key facts

- **Recall number:** Z-1429-2022
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-18
- **Report date:** 2022-07-27
- **Termination date:** 2024-12-23

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2022

## Citation

> AI Analytics. FDA recall Z-1429-2022. Retrieved 2026-07-18 from https://api.ai-analytics.org/recall/Z-1429-2022. Source: US FDA. Licensed CC0.

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