Class 2 Device Recall 8mm FlexDex Needle Driver

• Date Initiated by Firm: December 22, 2021
• Create Date: January 27, 2022
• Recall Status: Terminated on July 25, 2023
• Recall Number: Z-0531-2022
• Recall Event ID: 89316
• Product Classification: Instrument, manual, surgical, general use - Product Code MDM
• Product: 8mm FlexDex Needle Driver, Product Code FD-335 ND
• Code Information: All lots
• Recalling Firm/ Manufacturer: FlexDex Inc.; 10421 Citation Dr Ste 900; Brighton MI 48116-6558
• For Additional Information Contact: 810-522-9009
• Manufacturer Reason for Recall: The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
• FDA Determined Cause: Unknown/Undetermined by firm
• Action: The firm sent a letter to customers reiterating the IFU's statement "Do not use if package is damaged." This is important to ensure the sterility of the product. If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. Please forward this letter on to all those who need to be aware within your organization and to any other organizations (e.g. customers) on which this has an impact.
• Quantity in Commerce: 273
• Distribution: n/a
• 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.