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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap ENNOVATE SET SCREW STERILE

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  Class 2 Device Recall Aesculap ENNOVATE SET SCREW STERILE see related information
Date Initiated by Firm July 15, 2022
Create Date August 26, 2022
Recall Status1 Open3, Classified
Recall Number Z-1638-2022
Recall Event ID 90678
510(K)Number K180433  
Product Classification Thoracolumbosacral pedicle screw system - Product Code NKB
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
Code Information GUIDID: 04046964989728 Lot Number: 52758014
Recalling Firm/
Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Potential for the incorrect screw to be included in the package.
FDA Determined
Cause 2
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 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.
Quantity in Commerce 6 units
Distribution GA, TX
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = NKB and Original Applicant = Aesculap Implant Systems, LLC