Device recall

Z-0580-2026: Catalyft PL & PL40 Expandable Interbody System labeled as follows with…

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

Key facts

Recall number (Z-number) Z-0580-2026
Recall event 97714
Product Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER…
Product code MAX
Recalling firm Medtronic Sofamor Danek USA Inc
Recall class Class II
Status Open, Classified
510(k) numbers K210425
FEI number 1000477302

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

Browse all FDA device recalls (products)