---
title: "Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmenta... — FDA record Z-1638-2022 | Is It on Recall"
description: "Potential for the incorrect screw to be included in the package."
url: https://isitonrecall.com/recall/fda-device-z-1638-2022-aesculap-ennovate-set-screw-sterile-implants-are-used-for-dorsal-monosegmental-and-multisegmental-st/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of th... — FDA record Z-1638-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jul 15, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **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**: Potential for the incorrect screw to be included in the package.
- **Classification**: Class II
- **Recalling firm**: Aesculap Implant Systems LLC
- **Quantity**: 6 units
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-1638-2022

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1638-2022%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | GUIDID: 04046964989728 Lot Number: 52758014 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

GA, TX

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Georgia](https://isitonrecall.com/state/georgia/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Sep 7, 2022
- **Recall initiation date**: Jul 15, 2022
- **Center classification date**: Aug 26, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1638-2022%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Aesculap Implant Systems LLC records](https://isitonrecall.com/brand/aesculap-implant-systems-llc/)