Z-0361-2011

ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon...

Name: Z-0361-2011 ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon...
Creator: Ethicon Endo-Surgery Inc
Published: 2009-01-13
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2009-01-13 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969 on 2009-01-13. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0361-2011
Status: Terminated
Initiated: 2009-01-13
Posted: 2010-11-15
Terminated: 2012-05-10
Recalling firm: Ethicon Endo-Surgery Inc
Product: ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.
Product code: GDW Staple, Implantable
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 root cause: Other
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.
Product codes and lots: Lot #'s: E4MD1T, E4MD5W, E4MD3Y, E4ME7J, E4MD4Z, E4ME7U, E4MD50 & E4MF0A

Product code GDW

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)