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U.S. Department of Health and Human Services

Class 2 Device Recall TransTissue Filtron

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  Class 2 Device Recall TransTissue Filtron see related information
Date Initiated by Firm October 20, 2017
Create Date November 22, 2017
Recall Status1 Terminated 3 on October 09, 2018
Recall Number Z-0170-2018
Recall Event ID 78392
510(K)Number K092482  
Product Classification System, suction, lipoplasty - Product Code MUU
Product Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000.

Used for fat transfer and liposuction.
Code Information Lot 12004
Recalling Firm/
Shippert Medical Technologies
6248 S Troy Cir Ste A
Centennial CO 80111-6485
Manufacturer Reason
for Recall
Potential breach of sterility of the packaging.
FDA Determined
Cause 2
Packaging process control
Action A n Urgent: Medical Device Recall letter, dated October 20, 2017, was mailed to the user, identifying the affected device and describing the reason for the recall. The letter also provided the risk to health involved and discussed how the user can recognize the failure. Customers were instructed to remove all affected product from their inventory and quarantine them. Additionally, the letter should be forwarded to all necessary staff. Customers are to complete the Recall Response letter within 10 calendar days. Only the affected products listed should be returned per the instructions provided. Questions should be directed to Customer Service at 800-888-8663.
Quantity in Commerce 56 units
Distribution Worldwide Distribution -- United States, Australia, and Netherlands.
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 = SHIPPERT MEDICAL TECHNOLOGIES CORP.