FDA-Device2016-08-03Class II
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.
Integra LifeSciences Corp.
Hazard
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
Sold states
Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
Affected count
27 units
Manufactured in
311 Enterprise Dr, N/A, Plainsboro, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2296-2016Don't want to check this manually?
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