FDA-Device2015-02-18Class II
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.
Biomet Spine, LLC
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.
Sold states
Distributed to TX, OH, NE and NY.
Affected count
10
Manufactured in
310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1089-2015Don't want to check this manually?
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