—#95016

Product

ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Model # ATS45. Manfuactured by Ethicon Endo-Survery, LLC; 475 Calle C; Guaynabo PR 00969.

FDA product code: GDW — Staple, Implantable
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K020779, K070887
Affected lot / code info: Lot #'s: E4MD1T, E4MD5W, E4MD3Y, E4ME7J, E4MD4Z, E4ME7U, E4MD50 & E4MF0A

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Ethicon Endo-Surgery Inc
Address: 4545 Creek Rd, Cincinnati, Ohio 45242-2803

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-01-13
Posted by FDA: 2010-11-15
Terminated: 2012-05-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #95016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.