Telluride Percutaneous Rod Inserter Long, Model #7706-1904. The Inserter is a reusable device pr...
FDA Recall #Z-1089-2015 — Class II — December 19, 2011
Product Description
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.
Reason for Recall
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.
Recalling Firm
Biomet Spine, LLC — Broomfield, CO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10
Distribution
Distributed to TX, OH, NE and NY.
Code Information
LOT Numbers: L561968 and L570545 Product Code: 7703-1600
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated