Device recall

Z-0397-2016: IBS - Osteosynthesis screws for bone fixation Model S25 ST014.

FDA device recall · Class II · In2Bones, SAS

Key facts

Recall number (Z-number) Z-0397-2016
Recall event 72711
Product IBS - Osteosynthesis screws for bone fixation Model S25 ST014.
Product code HWC
Recalling firm In2Bones, SAS
Recall class Class II
Status Terminated
Termination date Aug 19, 2016
510(k) numbers K131920
FEI number 3010470577

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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