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U.S. Department of Health and Human Services

Class 2 Device Recall ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters

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 Class 2 Recall
ENDOPATH ETSFLEX45 Articulating Endoscopic Linear Cutters
see related information
Date Posted November 15, 2010
Recall Status1 Terminated on May 10, 2012
Recall Number Z-0361-2011
Recall Event ID 56940
Premarket Notification
510(K) Numbers
K020779  K070887 
Product Classification Staple, Implantable - Product Code GDW
Product ENDOPATH® ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.
Code Information Lot #'s: E4MD1T, E4MD5W, E4MD3Y, E4ME7J, E4MD4Z, E4ME7U, E4MD50 & E4MF0A
Recalling Firm/
Manufacturer
Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati, Ohio 45242-2803
For Additional Information Contact David E. Moore
513-337-3383
Manufacturer Reason
for Recall
The mechanism that connects the articulation joint to the device shaft may cause the jaws of the cutters to remain closed and clamped down on tissue after the device is fired. If the jaws of the device remain clamped down on the tissue, there is a risk the surgery will need to be modified to remove the device. This may lead to an increase in procedure time, tissue manipulation, and a change in t
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Ethicon Endo-Surgery issued "Urgent Device Recall Event 1952" notification letters dated January 21, 2009 to their customers. They instructed their custormers to immediately discontinue use of the product. They are to complete and fax back the Business Reply Form. Affected product is to be returned with a copy of the completed Business Reply Form to Stericycle. Replacement product should be received within 30-60 days after return. Customers can contact Stericycle concerning this recall at 1-866-861-6921, reference Event 1952.
Quantity in Commerce 4,113 UNITS
Distribution Worldwide Distribution: USA only, in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI. IA. ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, INC.
510(K)s with Product Code = GDW and Original Applicant = ETHICON ENDO-SURGERY, LLC
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