Recall Z-1453-2015 ยท OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
US Endoscopy Group Inc
Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the gastrointestinal tract.
| Date | Apr 16, 2015 (initiated Mar 10, 2015) |
| Status | Terminated |
| Reason | A wire component on the distal grasping assembly of the device became detached.. |
| Root cause | Under Investigation by firm |
| Action | On 03/25/2015 the firm sent recall notification letters to their customers via email. |
| Quantity | 1695 units |
| Distribution | Product was shipped to the following states: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI & WV. Product was also sent to the following countries: ARGENTINA, AUSTRALIA, BELGIUM, CAN |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962676 | DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE United States Endoscopy Group, Inc., Oct 4, 1996 |