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Recall Observatory FDA recall evidence

Device product

Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.

Z-0469-2016

November 24, 2015

Class II

Product summary

Firm
Instratek, Incorporated
Event
Event 72748
Status
Terminated
Classification
Class II
Quantity
39 units
Official record key
device-enforcement:Z-0469-2016

Official wording

Reason: The sterile blade will not fit into the handle provided with the ETTD system.

Code information: Lot number MDHZ620

Distribution pattern: US distribution to the states: TX, UT, NY and CO.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The sterile blade will not fit into the handle provided with the ETTD system.