Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provid...
FDA Recall #Z-1259-2013 — Class III — April 17, 2009
Product Description
Mercury Spinal System DIA 5.5 x 60mm Straight Rod, Part Number: 60101-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Reason for Recall
Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
Recalling Firm
Spinal Elements, Inc — Carlsbad, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
68 units total
Distribution
Distributed in OH and PA.
Code Information
Lot Number: 080594
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated