FDAClass IIMarch 15, 2017

MicroAire K-Wires recall: Labeling Error

MicroAire K-Wires

Why was MicroAire K-Wires recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.

Product
MicroAire K-Wires
Recalling firm
MicroAire Surgical Instruments, LLC
Quantity
Total 362
Distribution
United States.
Recall date
March 15, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
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