Device recall

Z-0574-2015: Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only…

FDA device recall · Class II · Zimmer, Inc.

Key facts

Recall number (Z-number) Z-0574-2015
Recall event 69613
Product Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile. The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fusion procedures.
Product code KWP
Recalling firm Zimmer, Inc.
Recall class Class II
Status Terminated
Termination date Feb 24, 2015
510(k) numbers K041808
FEI number 1000220733

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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