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

FDA device recall Z-1069-2011 · posted 2011-02-15 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

LRP

Quantity affected

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, N

Date initiated

2009-03-27

Date posted

2011-02-15

Date terminated

2013-02-15

Location

Cincinnati, OH

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