Device recall

Z-0895-2011: Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by…

FDA device recall · Class II · Stryker Spine

Key facts

Recall number (Z-number) Z-0895-2011
Recall event 57462
Product Disc Space Distractor Label states - Specialty Disc Space Distractor, Mfg by: Stryker Spine 2 Pearl Court Allendale, NJ 07401-1677 Used to assist in spinal fusions. It is to be placed between the vertebral bodies in the specified disc space; the t-handle can then be rotated clockwise expanding the…
Product code LXH
Recalling firm Stryker Spine
Recall class Class II
Status Terminated
Termination date Nov 14, 2012
FEI number 3004024955

At a glance

  • None 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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