Device recall

Z-0867-2019: Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation…

FDA device recall · Class II · Zimmer Biomet Spine Inc.

Key facts

Recall number (Z-number) Z-0867-2019
Recall event 82076
Product Vitality Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw is not threading…
Product code KWP
Recalling firm Zimmer Biomet Spine Inc.
Recall class Class II
Status Terminated
Termination date Apr 28, 2021
510(k) numbers K171907
FEI number 3012447612

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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