Recall Z-1407-2017— MicroAire Surgical Instruments, LLC

Name: FDA recall Z-1407-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-21

Class II · Terminated

Class II FDA medical device recall by MicroAire Surgical Instruments, LLC, initiated 2017-02-21, terminated 2017-07-14. It names one FDA 510(k) clearance: K863734. Product: MicroAire K-Wires. 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)..

Recalling firm: MicroAire Surgical Instruments, LLC
Classification: Class II
Status: Terminated
Initiated: 2017-02-21
Terminated: 2017-07-14
Firm location: Charlottesville, VA, United States

510(k) clearances named in this recall

1 on FDA's record

K863734 — STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINSMicro-Aire Surgical Instruments, Inc.·cleared 1986-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MicroAire K-Wires

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.