Z-1638-2022Class II

Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental...

Name: Z-1638-2022 Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental...
Creator: Aesculap Implant Systems LLC
Published: 2022-07-15
License: https://open.fda.gov/license/

Aesculap Inc / initiated 2022-07-15 / Open, Classified / root cause: packaging

FDA source

Aesculap Implant Systems LLC began a recall of Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine... on 2022-07-15. FDA classified it as Class II and gives the reason as "Potential for the incorrect screw to be included in the package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1638-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-15
Posted: 2022-08-26
Recalling firm: Aesculap Inc
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
Product code: NKB Thoracolumbosacral Pedicle Screw System
Reason for recall: Potential for the incorrect screw to be included in the package.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 6 units
Distribution: GA, TX
Product codes and lots: GUIDID: 04046964989728 Lot Number: 52758014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1638-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1638-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-09-07	2022-08-26

Product code NKB

K180433Class IIEnnovate®Aesculap Implant Systems, LLC / cleared 2018-04-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)