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U.S. Department of Health and Human Services

Class 2 Device Recall The Cellfina System

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  Class 2 Device Recall The Cellfina System see related information
Date Initiated by Firm November 14, 2016
Date Posted December 13, 2016
Recall Status1 Terminated 3 on September 13, 2017
Recall Number Z-0749-2017
Recall Event ID 75682
510(K)Number K161885  
Product Classification Powered surgical instrument for improvement in the appearance of cellulite - Product Code OUP
Product Cellfina Prep Pack, Part No. CP1
Code Information all
Recalling Firm/
Manufacturer
Ulthera Inc
1840 S Stapley Dr Ste 200
Mesa AZ 85204-6681
For Additional Information Contact Ulthera Customer Service
480-619-4069
Manufacturer Reason
for Recall
It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.
FDA Determined
Cause 2
Other
Action Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at mymerzsolutions@merz.com.
Quantity in Commerce 6562 units
Distribution Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)
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 = OUP and Original Applicant = ULTHERA, INC.
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