• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Ultrasonic Surgical Aspirator

  • 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 Ultrasonic Surgical Aspirator see related information
Date Initiated by Firm August 13, 2003
Date Posted October 30, 2003
Recall Status1 Terminated 3 on February 07, 2005
Recall Number Z-0070-04
Recall Event ID 27501
510(K)Number K933559  
Product Classification Instrument, Ultrasonic Surgical - Product Code LFL
Product LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURED BY: MISONIX, INC. EXCLUSIVELY FOR SALE BY MENTOR CORPORATION UNDER EXCLUSIVE LICENSE FROM SONIQUE SURGICAL, INC. MISONIX, INC. 1938 NEW HIGHWAY, FARMINGDALE, NY 11735.

Device was manufactured from September 1996 to present.
Code Information Serial numbers between 0100 and 1219 (inclusive)
Recalling Firm/
Manufacturer
Misonix, Inc
1938 New Highway
Farmingdale NY 11735-1204
For Additional Information Contact Mr. Ronald R. Manna
631-694-9555
Manufacturer Reason
for Recall
Firm received complaints of tingling or static shock sensation to end users caused by forcing the output connector into its receptacle misaligned. The misalignment causes additional voltage to appear on the patient probe.
FDA Determined
Cause 2
Other
Action Misonix, Inc. notified the sole direct consignee, Byron Medical Inc., of the "Corrective Action" by letter on 8/13/03. On 9/17/03, Byron Medical Inc. notified the end users by letter, and provided instructions for proper assembly and warning labels to be affixed to the units.
Quantity in Commerce 1119 units (potentially)
Distribution 1 distributor in Tucson, AZ, for further distribution to end users (physicians and medical facilities) nationwide & Puerto Rico, and in the following countries: Canada, Mexico, Australia, Switzerland, Israel, Saudi Arabia, Cyprus, Greece, Turkey, Germany, Dominican Republic, Sweden, Netherlands, China, Taiwan ROC, and S. Korea.
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 = LFL and Original Applicant = MEDSONIC, INC.
-
-