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Recall Observatory FDA recall evidence

Device product

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.

Z-1453-2015

March 10, 2015

Class II

Product summary

Firm
US Endoscopy Group Inc
Event
Event 70872
Status
Terminated
Classification
Class II
Quantity
1695 units
Official record key
device-enforcement:Z-1453-2015

Official wording

Reason: A wire component on the distal grasping assembly of the device became detached..

Code information: Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    A wire component on the distal grasping assembly of the device became detached..