Class 2 Device Recall ENNOVATE

• Date Initiated by Firm: November 18, 2020
• Create Date: July 21, 2022
• Recall Status: Completed
• Recall Number: Z-1429-2022
• Recall Event ID: 90526
• Product Classification: Orthopedic manual surgical instrument - Product Code LXH
• Product: ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
• Code Information: UDI-DI: 04046964719622
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: 800-258-1946
• Manufacturer Reason for Recall: Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system. Redesign of removal key.
• FDA Determined Cause: Component design/selection
• Action: An Urgent Field Safety Notification was issued November 18, 2020 sent USPS certified mail to distributors regarding removal of Ennovate Removal Key Short (SZ380) from the field. The affected Ennovate MIS Removal Key Short (SZ380R) in the field is to be exchanged with an improved design version under the same article number manufactured after June 01, 2020. Distributors are to identify and notify customers of this action. Distributors and customers are to identify the affected version in inventory and return it to Aesculap and submit the Acknowledgment Form via email at qa-recalls@aesculapusa.com.
• Quantity in Commerce: 17
• Distribution: United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & 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.