Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1453-2015Class II

Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones...

United States Endoscopy Group, Inc. / initiated 2015-03-10 / Terminated

US Endoscopy Group Inc began a recall of Talon Grasping Device, 160 cm, US endoscopy. Used for retrieval of foreign bodies, tissue specimens, stones or calculi in endoscopic procedures of the... on . FDA classified it as Class II and gives the reason as "A wire component on the distal grasping assembly of the device became detached". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1453-2015
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
United States Endoscopy Group, Inc.
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.
Product code
OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Reason for recall
A wire component on the distal grasping assembly of the device became detached..
FDA root cause
Under Investigation by firm
Action
On 03/25/2015 the firm sent recall notification letters to their customers via email.
Quantity in commerce
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, CANADA, ESTONIA, FRANCE, MEXICO, NEW ZEALAND, SAUDI ARABIA & SWEDEN.
Product codes and lots
Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1453-2015
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1453-2015Class IITerminatedVoluntary: Firm initiated