FDASeptember 8, 2015device
Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Inserter Inner Shaft would not fit through the Inserter. The inner diameter of the cannulated shaft of the inserter was undersized.
What to do
FDA enforcement status: Terminated
Brands named
stryker spinestryker
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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