Class 2 Device Recall Hydrocision

• Date Initiated by Firm: September 07, 2006
• Date Posted: November 02, 2006
• Recall Status: Terminated on December 06, 2006
• Recall Number: Z-0124-2007
• Recall Event ID: 36240
• 510(K)Number: K032529
• Product Classification: tissue ablating handpiece - Product Code HRX
• Product: Hydrocision SpineJet XL MIS 30 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone. Catalog Number 58663
• Code Information: Lot Number 75GF2530
• Recalling Firm/ Manufacturer: Hydrocision, Inc.; 22 Linnell Cir Ste 102; Billerica MA 01821-3901
• Manufacturer Reason for Recall: Distal tip may become detached from the device
• FDA Determined Cause: Process change control
• Action: Hydrocision contacted customers and sales reps by email on 9/6/06 advising to users to discontinue use and return recalled units.
• Quantity in Commerce: 40 total
• Distribution: 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.

• 510(K) Database: 510(K)s with Product Code = HRX