Recall Z-0469-2016 ยท HRX Arthroscope
Instratek, Incorporated
Hook Blade, Angled. Part number 7058A. Sterile disposable blade for use with Endoscopic Tarsal Tunnel Decompression (ETTD) System.
| Date | Dec 22, 2015 (initiated Nov 24, 2015) |
| Status | Terminated |
| Reason | The sterile blade will not fit into the handle provided with the ETTD system. |
| Root cause | Employee error |
| Action | 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' |
| Quantity | 39 units |
| Distribution | US distribution to the states: TX, UT, NY and CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.