# FDA recall Z-1638-2022

> **Aesculap Implant Systems LLC** · Class II · device recall initiated 2022-07-15.

## Product

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine.  Article Number:	52758014

## Reason for recall

Potential for the incorrect screw to be included in the package.

## Distribution

GA, TX

## Key facts

- **Recall number:** Z-1638-2022
- **Recalling firm:** Aesculap Implant Systems LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-07-15
- **Report date:** 2022-09-07

- **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-1638-2022

## Citation

> AI Analytics. FDA recall Z-1638-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1638-2022. Source: US FDA. Licensed CC0.

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