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U.S. Department of Health and Human Services

Class 2 Device Recall 8mm FlexDex Needle Driver

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  Class 2 Device Recall 8mm FlexDex Needle Driver see related information
Date Initiated by Firm December 22, 2021
Create Date January 27, 2022
Recall Status1 Terminated 3 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 2		 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.
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