Device recall

Z-1810-2012: T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a…

FDA device recall · Class II · Stryker Instruments Div. of Stryker Corporation

Key facts

Recall number (Z-number) Z-1810-2012
Recall event 61848
Product T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a barrier between the operating room and the members of the surgical team in order to help protect against contamination and/or exposure of infectious body fluids and harmful microorganisms.
Product code FYA
Recalling firm Stryker Instruments Div. of Stryker Corporation
Recall class Class II
Status Terminated
Termination date Apr 14, 2014
510(k) numbers K944393
FEI number 1811755

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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