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U.S. Department of Health and Human Services

Class 2 Device Recall Hydrocision

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  Class 2 Device Recall Hydrocision see related information
Date Initiated by Firm September 07, 2006
Date Posted November 02, 2006
Recall Status1 Terminated 3 on December 06, 2006
Recall Number Z-0123-2007
Recall Event ID 36240
510(K)Number K032529  
Product Classification tissue ablating handpiece - Product Code HRX
Product HydroCision SpineJet XL MIS 20 degree Handpieces, for cutting, ablation, and removal of soft tissue, hard tissue, and bone.

Catalog Number 58662
Code Information Lot Number 75GF2531
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 2		 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 and Original Applicant = HYDROCISION, INC.
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