ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 47

FDA device recall Z-0361-2011 · posted 2010-11-15 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

GDW

Quantity affected

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, O

Date initiated

2009-01-13

Date posted

2010-11-15

Date terminated

2012-05-10

Location

Cincinnati, OH

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