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U.S. Department of Health and Human Services

Class 2 Device Recall FlexTray Procedure Delivery System

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  Class 2 Device Recall FlexTray Procedure Delivery System see related information
Date Initiated by Firm March 27, 2009
Date Posted February 15, 2011
Recall Status1 Terminated 3 on February 15, 2013
Recall Number Z-1069-2011
Recall Event ID 57580
510(K)Number K061156  
Product Classification Surgical Tray - Product Code LRP
Product 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.
Code Information Lot Numbers: E4MR6R, E4ML22, E4MG62, E4MJ7M, and E4MN2V.
Recalling Firm/
Manufacturer		 Ethicon Endo-Surgery Inc
4545 Creek Rd
Cincinnati OH 45242-2803
For Additional Information Contact David E. Moore
513-337-7000
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 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. 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 1-888-365-4680, reference Event 1981.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LRP and Original Applicant = ETHICON ENDO-SURGERY, INC.
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