Z-0470-2021 Class II Terminated
FDA device recall Z-0470-2021 was initiated by Micro-Tech Usa on October 5, 2020 and is designated Class II. 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. The recall status is terminated (terminated December 2, 2021). Affected quantity: 2420 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- October 5, 2020
- Termination Date
- December 2, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2420 pieces
Product Description
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.
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.
Distribution Pattern
US Nationwide distribution including in the states of AZ, CA, CO, CT, IL, MA, MI, NY, OH, PR, TX, VA. No OUS distribution.
Code Information
Lots M190808231 M191018231 M191224231 M200305232