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

• Date Initiated by Firm: July 27, 2007
• Date Posted: September 20, 2007
• Recall Status: Terminated 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
• FEI Number: 1000118360
• 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: 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