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U.S. Department of Health and Human Services

Class 2 Device Recall Talon Grasping Device

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  Class 2 Device Recall Talon Grasping Device see related information
Date Initiated by Firm March 10, 2015
Date Posted April 16, 2015
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-1453-2015
Recall Event ID 70872
510(K)Number K962676  
Product Classification Endoscopic grasping/cutting instrument, non-powered - Product Code OCZ
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.
Code Information Model #00711175; Lot #'s: 1407418, 1407419, 1408069, 1408070, 1408739, 1408740, 1408741, 1408742, 1410178, 1410179, 1410478, 1410480, 1410990, 1411518, 1423937, and 1423938.
Recalling Firm/
Manufacturer		 US Endoscopy Group Inc
5976 Heisley Rd
Mentor OH 44060-1873
For Additional Information Contact Ms. Kia (NMI) Pennington
800-769-8226
Manufacturer Reason
for Recall		 A wire component on the distal grasping assembly of the device became detached..
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OCZ and Original Applicant = UNITED STATES ENDOSCOPY GROUP, INC.
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