MicroAire K-Wires
This recall has been terminated (originally issued March 3, 2017).
- Recall Initiated
- February 21, 2017
- Posted
- March 3, 2017
- Terminated
- July 14, 2017
- Recall Number
- Z-1407-2017
- Quantity
- Total 362
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
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).
Distribution
United States.
Lot / Code Info
Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
Root Cause
Labeling mix-ups
Action Taken
The firm will mail recall letters to the customers who received the mislabeled k-wires on February 21, 2017. Letters will be sent by UPS to expedite the delivery. The firm will contact the non-responding accounts at least two more times.
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