Device recall

Z-1421-2013: Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide…

FDA device recall · Class II · Alphatec Spine, Inc.

Key facts

Recall number (Z-number) Z-1421-2013
Recall event 65165
Product Leucadia Autolok" Polyaxial Pedicle Screw System. Intended to help provide correction, immobilization and stabilization of spinal segments.
Product code NKB
Recalling firm Alphatec Spine, Inc.
Recall class Class II
Status Terminated
Termination date Sep 25, 2014
510(k) numbers K113366
FEI number 2027467

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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