Device product
MicroAire K-Wires
Z-1407-2017
Product summary
- Event
- Event 76560
- Status
- Terminated
- Classification
- Class II
- Quantity
- Total 362
- Official record key
device-enforcement:Z-1407-2017
Official wording
Reason: 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).
Code information: Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
Distribution pattern: United States.
Derived failure modes
-
Labeling or packaging
Mislabeling