ENNOVATE recallZ-1638-2022 · Aesculap Implant Systems LLC · initiated Jul 15, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Aesculap Implant Systems LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for the incorrect screw to be included in the package.
FDA root cause category: Under Investigation by firm
What the company is doing
Aesculap Implant Systems, LLC. issued Urgent Medical Device Removal/Recall letter on 7/15/22. Letter states reason for recall, health risk and action to take: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the end user/customer level. 2. Determine your current inventory of the affected lots within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached Product Removal Acknowledgement, form, record the total number of individual units in your possession. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Removal Acknowledgement form to the Quality Assurance department via e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the Product Removal Acknowledgement form that was submitted to the Quality Assurance Department, a Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to our distribution center. This may include credit or replacement product. Should you identify a problem or safety concern with the product, please report the event promptly by contacting our Postmarket Surveillance Department at 1-833-425-1464.
Recall details
- Recall number
- Z-1638-2022
- Status
- Open, Classified
- Initiated by the company
- Jul 15, 2022
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 6 units
- Product code
- NKB
- FDA submissions
- K180433
- Distribution
- GA, TX
Product description
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Code information (models, lots, serial numbers)
GUIDID: 04046964989728 Lot Number: 52758014
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ENNOVATE SY001TSAesculap AG · Thoracolumbosacral pedicle screw system1 recall4 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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