MicroAire K-Wires recallZ-1407-2017 · MicroAire Surgical Instruments, LLC · initiated Feb 21, 2017
Class II Terminated All recalls posted in March 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MicroAire Surgical Instruments, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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).
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1407-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 21, 2017
- Posted by the FDA
- Mar 3, 2017
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Quantity
- Total 362
- Product code
- HTY
- FDA submissions
- K863734
- Distribution
- United States.
Product description
MicroAire K-Wires
Code information (models, lots, serial numbers)
Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
Other devices under the same FDA submission
1 device cleared under K863734 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MicroAire® 1600-645Microaire Surgical Instruments LLC · Pin, Fixation, Smooth2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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