Device recall

Z-1069-2011: FlexTray Procedure Delivery System, Product Codes: KBW71SXL- Bariatric Surgery…

FDA device recall · Class II · Ethicon Endo-Surgery Inc

Key facts

Recall number (Z-number) Z-1069-2011
Recall event 57580
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
Recalling firm Ethicon Endo-Surgery Inc
Recall class Class II
Status Terminated
Termination date Feb 15, 2013
510(k) numbers K061156
FEI number 1527736

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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