Device recall

Z-0138-2008: Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial…

FDA device recall · Class II · Medtronic Sofamor Danek USA Inc

Key facts

Recall number (Z-number) Z-0138-2008
Recall event 44953
Product Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL: Stainless Steel/Titanium, Rx only, Manufactured at: Bartlett, Tennessee USA
Product code MJO
Recalling firm Medtronic Sofamor Danek USA Inc
Recall class Class II
Status Terminated
Termination date Nov 3, 2008
PMA numbers P060018
FEI number 1000477302

At a glance

  • None 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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