FDADecember 19, 2011device
Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an aluminum sterilization case along with other orthopedic manual surgical instruments. The case consists of three trays of instruments, and the middle tray contains a quantity of two Ins...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The Telluride Percutaneous Rod Inserter Long does not contain a feature that locks the Rod in place during use. There is a potential for the Rod to disengage from the Inserter during insertion, and could lead to harm to the patient.
What to do
FDA enforcement status: Terminated
Brands named
biomet spinebiomet
Recall history
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