Recall Z-1068-2011 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Ethicon Endo-Surgery Inc
ENDOPATH ETS-FLEX45 Articulating Endoscopic Linear Cutters, Product Codes: ATS45; LONG45A; 6TB45; ATG45; ATB45; ATW45; ATS45NK; and NAW45. Intended for transection, resection, and/or creation of anastomoses.
| Date | Feb 15, 2011 (initiated Mar 27, 2009) |
| Status | Terminated |
| Reason | The firm initiated this second subsequent recall because the affected devices can remain closed and clamped on tissue during surgical procedures due to the fact that the mechanism which connects the articulation joint to the device shaft is insufficient. |
| Root cause | Other |
| Action | Ethicon Endo-Surgery issued "Urgent Expanded Device Recall Event 1981" notification letters dated April 7, 2009, to their customers. They provided a list of all Affected Product Codes of the ETS FLEX45 Articulating Endoscopic Linear Cutters (including the Product Code: ATS45 from the 1st recall) and Affected Flex Tray Codes subject to recall. The notification document reminds the Operating Room and Materials Management customers of the problem which necessitated the previous recall (Z-0361-2011). It goes on to instruct their customers to immediately discontinue use of the affected products. |
| Quantity | 29,403 units |
| Distribution | Nationwide Distribution -- USA including the following states, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MO, MS, MT, NC, NE, NH, NJ, MN, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, and Puerto Rico. |
| FDA record | Open on fda.gov |