FDAJuly 1, 2016device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
What to do
FDA enforcement status: Terminated
Brands named
integra lifesciencesintegra
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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