Device recall

Z-1565-2014: SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT…

FDA device recall · Class II · SpineFrontier, Inc.

Key facts

Recall number (Z-number) Z-1565-2014
Recall event 63145
Product SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Product code MAX
Recalling firm SpineFrontier, Inc.
Recall class Class II
Status Terminated
Termination date May 20, 2014
510(k) numbers K092815
FEI number 3005977257

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

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