Class 2 Device Recall Modulift VBR Medium Set Screwdrivers

• Date Initiated by Firm: October 25, 2021
• Create Date: July 19, 2022
• Recall Status: Terminated on June 12, 2024
• Recall Number: Z-1410-2022
• Recall Event ID: 90544
• Product Classification: Screwdriver - Product Code HXX
• Product: MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
• Code Information: UDI-DI: 04046964067648
• Recalling Firm/ Manufacturer: Aesculap Implant Systems LLC; 3773 Corporate Pkwy; Center Valley PA 18034-8217
• For Additional Information Contact: Customer Service; 866-229-3002
• Manufacturer Reason for Recall: Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
• FDA Determined Cause: Component design/selection
• Action: An Urgent Medical Device Removal Notification was issued October 25, 2021 sent via email and USPS certified mail. The notice identified the product MODULIFT VBR SZ.M 4MM SET SCREWDRIVER, part of Modulift VBR Medium Instrument Set, ST-0441 and requested customers identify and quarantine affected inventory, submit the acknowledgement form and contact AIS Customer Service to arrange for return of product at (866) 229-3002 and SetWorld_orders.BBMUS_Service@aesculapimplants.com. Distributors are to notify customers if product was further distributed.
• Quantity in Commerce: 9 pieces
• Distribution: US: CA, FL, GA, IL, OH & MI
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.