Recall Z-1069-2011 ยท LRP Tray, Surgical
Ethicon Endo-Surgery Inc
FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and XBB65S - Bariatric Surgery Trays. 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 | 135 kits |
| 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 |
510(k) clearances named in this recall
| K061156 | ENDOPATH ENDOCUTTER 60 ENDOSCOPIC LINEAR CUTTER, MODELS EC60, SC60 AND LONG60 AND ENDOPATH & PROXIMATE LINEAR CUTTERS Ethicon Endo-Surgery, Inc., Jul 3, 2006 |