Device product
Integra External Fixation System Rocker Bottom Model # 12225400. For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
Z-2296-2016
Product summary
- Event
- Event 74583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 27 units
- Official record key
device-enforcement:Z-2296-2016
Official wording
Reason: The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Code information: Lot # PN625.
Distribution pattern: Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
Derived failure modes
-
Unknown
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.