Aesculap Implant Systems LLC Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
GUIDID: 04046964989728 Lot Number: 52758014
Products Sold
GUIDID: 04046964989728 Lot Number: 52758014
Aesculap Implant Systems LLC is recalling Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental st due to Potential for the incorrect screw to be included in the package.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for the incorrect screw to be included in the package.
Recommended Action
Per FDA guidance
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 qa-recalls@aesculapusa.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
GA, TX
Page updated: Jan 10, 2026