Home / Recalls / Medical Devices
Biomet Spine, LLC recalls Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an alumin
Recalled February 18, 2015 · FDA recall Z-1089-2015 · Biomet Spine
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. · FDA Class II
Units
10
Sold at
Distributed to TX, OH, NE and NY.
Description
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.
Product
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 Inserters. The Inserter is for use as part of a Telluride System pedicle screw procedure.
Manufacturer(s)
Biomet Spine, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →