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.
FDA Recall Z-1453-2015 · Posted 2015-04-16
Advertisement
Recalling FirmUS Endoscopy Group Inc
Recall StatusTerminated
Product CodeOCZ
Date Initiated2015-03-10
Date Terminated2016-10-27
Product Quantity1695 units
Reason for Recall
A wire component on the distal grasping assembly of the device became detached..
Firm Action
On 03/25/2015 the firm sent recall notification letters to their customers via email.
Root Cause
Under Investigation by firm
Distribution Pattern
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, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement