Device recall

Z-0752-2013: Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw…

FDA device recall · Class II · Extremity Medical LLC

Key facts

Recall number (Z-number) Z-0752-2013
Recall event 63805
Product Extremity Medical, IO FiX System Accessory. Catalog Number 101-00010. This screw measuring device is an accessory to the IO FiX Screw and Washer System that is used to measure the length of the screw by placing the depth gauge over the guidewire and down to the bone. Orthopedic device.
Product code HWC
Recalling firm Extremity Medical LLC
Recall class Class II
Status Terminated
Termination date Jun 13, 2013
510(k) numbers K101700
FEI number 3007289093

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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