Biomet Spine, LLC recalls Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device provided within an alumin…

Recall date

December 19, 2011

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1089-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

Distributed to TX, OH, NE and NY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.