Z-1069-2011

FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric...

Name: Z-1069-2011 FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric...
Creator: Ethicon Endo-Surgery Inc
Published: 2009-03-27
License: https://open.fda.gov/license/

Ethicon Endo-Surgery Inc / initiated 2009-03-27 / Terminated

FDA source

Ethicon Endo-Surgery Inc began a recall of FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery Trays, TBW13SXL- Bariatric Surgery Trays, XBB14B - Bariatric Surgery Trays, and... on 2009-03-27. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1069-2011
Status: Terminated
Initiated: 2009-03-27
Posted: 2011-02-15
Terminated: 2013-02-15
Recalling firm: Ethicon Endo-Surgery Inc
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.
Product code: LRP Tray, Surgical
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 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. 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.
Product codes and lots: Lot Numbers: E4MR6R, E4ML22, E4MG62, E4MJ7M, and E4MN2V.

Product code LRP

K061156Class IIEndopath Endocutter 60 Endoscopic Linear Cutter, Models Ec60, Sc60 and Long60 and Endopath & Proximate Linear CuttersEthicon Endo-Surgery, Inc. / cleared 2006-07-03

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)