[Recalled] MicroAire K-Wires — Mislabeling on three lots of K-Wires | FDA 2017-02-21
The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.
Recall details
| Product | MicroAire K-Wires |
|---|---|
| Brand / manufacturer | MicroAire Surgical Instruments, LLC |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1407-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 February 2017 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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).
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from MicroAire Surgical Instruments, LLC
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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