FDAFDA · Food and drugs·Recall number Z-1407-2017
MicroAire K-Wires
Published March 15, 2017 · Recall initiated: February 21, 2017
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
Mislabeling on three lots of K-Wires. The incorrect product description " dual trocar" instead of "single trocar" was on the product label on the following parts: 1600-9355NS (lot 61005), 1600-9625NS (lot 60297), and 1604-162NS (lot 62856).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MicroAire Surgical Instruments, LLC
- Distributor
- United States.
- Lot
- Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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