Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  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 February 14, 2017
Recall Number Z-1328-2016
Recall Event ID 73373
Product Classification Cannula, surgical, general & plastic surgery - Product Code GEA
Product MicroAire PAL¿ Cannula

Product Usage - Power Aspiration Device
Code Information Include lot numbers/serial numbers  0913228216, 0414243005, 0215266350, 0415269875, 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		 MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
FDA Determined
Cause 2		 Nonconforming Material/Component
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 145 manufactured and distributed
Distribution Worldwide Distribution - US Nationwide
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.
-
-