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

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

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.