Class 2 Device Recall 40cm x 4mm Del Vecchio French Rasp cannula

• Date Initiated by Firm: February 08, 2016
• Create Date: April 05, 2016
• Recall Status: Terminated on August 12, 2016
• Recall Number: Z-1323-2016
• Recall Event ID: 73259
• 510(K)Number: K973268
• Product Classification: Pump, portable, aspiration (manual or powered) - Product Code BTA
• Product: MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
• Code Information: 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.
• FEI Number: 2020601
• 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: Complaints that the cannula bent/broke during surgery.
• FDA Determined Cause: Component design/selection
• Action: The firm is sending letters to all customers who have received PAL-R4011XL from August 2013- October 2015. The firm sent these letters by UPS to expedite the delivery and for traceability.
• Quantity in Commerce: 37
• Distribution: Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey.
• 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 = BTA