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U.S. Department of Health and Human Services

Class 3 Device Recall 5mm X 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe

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  Class 3 Device Recall 5mm X 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe see related information
Date Initiated by Firm July 27, 2007
Date Posted September 20, 2007
Recall Status1 Terminated 3 on April 04, 2008
Recall Number Z-1230-2007
Recall Event ID 38623
510(K)Number K041058  
Product Classification Ultrasonic Aspiration Probe - Product Code MUU
Product 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530.
Code Information Serial numbers: 0028-05, 0035-05, 0069-05, and 0092-05
Recalling Firm/
Manufacturer		 Mentor Texas, Inc
3041 Skyway Cir N
Irving TX 75038-3500
For Additional Information Contact
972-252-6060
Manufacturer Reason
for Recall		 Mis-identified and mis-labeled surgical probes were distributed. 5mm x 30cm Hollow "Golf" Tip Ultrasonic Aspiration Probe, Model 5620-530, Catalog Number 5620-530 was shipped, instead of LySonix 5mm x 30cm Hollow Bullet Tip Ultrasonic Probe, Catalog Number 5610-530.
FDA Determined
Cause 2		 Other
Action Firm notified consignees by letter on July 27, 2007.
Quantity in Commerce 4 units
Distribution Nationwide, including VA, IN, CA, and IL.
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 = MUU and Original Applicant = MISONIX, INC.
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