Device recall

Z-1348-2009: Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling…

FDA device recall · Class II · Synthes Spine

Key facts

Recall number (Z-number) Z-1348-2009
Recall event 51781
Product Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
Product code ODP
Recalling firm Synthes Spine
Recall class Class II
Status Terminated
Termination date Oct 5, 2009
510(k) numbers K072981
FEI number 3005180112

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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