FDAFDA · Food and drugs·Recall number Z-0469-2016
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
Published December 30, 2015 · Recall initiated: November 24, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The sterile blade will not fit into the handle provided with the ETTD system.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Instratek, Incorporated
- Distributor
- US distribution to the states: TX, UT, NY and CO.
- Lot
- Lot number MDHZ620
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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