Class II — MicroAire Surgical Instruments, LLC
| Recalling firm | MICROAIRE SURGICAL INSTRUMENTS, LLC |
|---|---|
| Registered facility | MICROAIRE SURGICAL INSTRUMENTS LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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). |
| Product | MicroAire K-Wires |
| Quantity | Total 362 |
| Distribution | United States. |
| Initiated | 2017-02-21 |
| Classified | 2017-03-03 |
| Terminated | 2017-07-14 |
| Recall number | Z-1407-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — MicroAire Surgical Instruments, LLC (Z-1407-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76560/
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