FDAJune 26, 2018device
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
What to do
FDA enforcement status: Terminated
Brands named
encore medical lpencoreencore medical
Recall history
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