Recall Z-1407-2017 ยท HTY Pin, Fixation, Smooth
MicroAire Surgical Instruments, LLC
MicroAire K-Wires
| Date | Mar 3, 2017 (initiated Feb 21, 2017) |
| 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). |
| Root cause | Labeling mix-ups |
| Action | 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. |
| Quantity | Total 362 |
| Distribution | United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K863734 | STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINS Micro-Aire Surgical Instruments, Inc., Oct 20, 1986 |