Device Recall Endoscopic Tarsal Tunnel Decompression 의 리콜

Recall

72748

Class 2

Z-0469-2016

2015-11-24

2015-12-22

Terminated

United States

2016-06-27

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142098

The sterile blade will not fit into the handle provided with the ettd system.

Instratek contacted customers by phone call either by direct contact or voice mail message on November 23, 2015. that a recall was being initiated. Formal letters were sent via UPS to the Customers annoucing the recall on November 24, 2015. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product,please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. You should contact lnstratek's Customer service for a return authorization number and further instructions for return of unused product.