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U.S. Department of Health and Human Services

Class 2 Device Recall Elastic Traction Device

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  Class 2 Device Recall Elastic Traction Device see related information
Date Initiated by Firm October 05, 2020
Create Date November 18, 2020
Recall Status1 Terminated 3 on December 02, 2021
Recall Number Z-0470-2021
Recall Event ID 86608
Product Classification Ligator, esophageal - Product Code MND
Product Elastic Traction Device, 11mm Lower. UPN: ER56041
Reference Number: ETD-D-26-235-C-N - Product Usage: indicated for use in flexible Endoscopy to provide retraction to assist in tissue resection, exposure, and removal of tissue within the gastrointestinal tract.
Code Information Lots M190808231 M191018231 M191224231 M200305232 
Recalling Firm/
Manufacturer		 Micro-Tech Usa
2855 Boardwalk St
Ann Arbor MI 48104-6715
For Additional Information Contact Celina Call
877-552-4027
Manufacturer Reason
for Recall		 FDA has informed Micro-Tech that the Elastic Traction Device is not appropriately classified as a Class I device and requires 510(k) clearance to be marketed in the US.
FDA Determined
Cause 2		 No Marketing Application
Action On October 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers, advising them that the firm is voluntarily recalling the Elastic Traction Device. Further distribution or use of any remaining product should cease immediately. Customers were asked to identify and quarantine devices left in inventory. They should complete the customer Acknowledgement and Receipt Form accompanying the letter and return the form to Micro-Tech Endoscopy USA. If product is available for return, the firm will contact your facility to create a Returned Material Authorization with shipping instructions. Customers should pass the notice on to all those who need to be aware within their organization, or to any organization where the affected devices have been transferred.
Quantity in Commerce 2420 pieces
Distribution US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
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.
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