Device recall

Z-1881-2016: Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw…

FDA device recall · Class II · Orthofix, Inc

Key facts

Recall number (Z-number) Z-1881-2016
Recall event 73978
Product Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
Product code HXX
Recalling firm Orthofix, Inc
Recall class Class II
Status Terminated
Termination date Nov 23, 2016
510(k) numbers K153428
FEI number 2183449

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 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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