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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Product Detail

Product Description Mercury Spinal System DIA 5.5 x 100mm Straight Rod, Part Number: 60101-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients.
Recall Number Z-1263-2013
Classification Class III
Code Info Lot Number: 080599
Product Distributed Qty 68 units total
Reason For Recall Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.

Event Detail

Event Id 53487
Product Type Devices
Status Terminated
Recalling Firm Spinal Elements, Inc
City Carlsbad
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-04-17
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Distributed in OH and PA.