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U.S. Department of Health and Human Services

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

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  Class 2 Device Recall 40cm x 4mm Del Vecchio French Rasp cannula see related information
Date Initiated by Firm February 08, 2016
Create Date April 05, 2016
Recall Status1 Terminated 3 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.    
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 2		 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 and Original Applicant = MICROAIRE SURGICAL INSTRUMENTS, INC.
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