Class 2 Device Recall MicroAire KWires

• Date Initiated by Firm: February 21, 2017
• Date Posted: March 03, 2017
• Recall Status: Terminated on July 14, 2017
• Recall Number: Z-1407-2017
• Recall Event ID: 76560
• 510(K)Number: K863734
• Product Classification: Pin, fixation, smooth - Product Code HTY
• Product: MicroAire K-Wires
• Code Information: Part Number, Lot Number, Quantity Distributed to Field 1600-9355NS, 61005, 56; 1600-9625NS, 60297, 209; 1604-162NS, 62856, 97.
• Recalling Firm/ Manufacturer: MicroAire Surgical Instruments, LLC; 3590 Grand Forks Blvd; Charlottesville VA 22911-9006
• For Additional Information Contact: 434-975-8000
• Manufacturer 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).
• FDA Determined 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 in Commerce: Total 362
• Distribution: United States.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HTY and Original Applicant = MICRO-AIRE SURGICAL INSTRUMENTS, INC.