MicroAire K-Wires
FDA device recall Z-1407-2017 · posted 2017-03-03 · Terminated
Recall details
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- HTY
- Quantity affected
- Total 362
- Distribution
- United States.
- Date initiated
- 2017-02-21
- Date posted
- 2017-03-03
- Date terminated
- 2017-07-14
- Location
- Charlottesville, VA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS (K863734) | Micro-Aire Surgical Instruments, Inc. | 1986-10-20 |