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Recall Observatory FDA recall evidence

Device product

8mm FlexDex Needle Driver, Product Code FD-335 ND

Z-0531-2022

December 22, 2021

Class II

Product summary

Firm
FlexDex Inc.
Event
Event 89316
Status
Terminated
Classification
Class II
Quantity
273
Official record key
device-enforcement:Z-0531-2022

Official wording

Reason: 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.

Code information: All lots

Distribution pattern: Unavailable

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.