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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080602 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1266-2013
Mercury Spinal System DIA 5.5 x 120mm Straight Rod, Part Number: 60101-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080601 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1265-2013
Mercury Spinal System DIA 5.5 x 110mm Straight Rod, Part Number: 60101-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080600 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1264-2013
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. Lot Number: 080599 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1263-2013
Mercury Spinal System DIA 5.5 x 90mm Straight Rod, Part Number: 60101-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080598 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1262-2013
Mercury Spinal System DIA 5.5 x 80mm Straight Rod, Part Number: 60101-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080597 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1261-2013
Mercury Spinal System DIA 5.5 x 70mm Straight Rod, Part Number: 60101-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080596 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1260-2013
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. Lot Number: 080594 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1259-2013
Mercury Spinal System DIA 5.5 x 50mm Straight Rod, Part Number: 60101-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080594 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1258-2013
Mercury Spinal System DIA 5.5 x 40mm Straight Rod, Part Number: 60101-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080593 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1257-2013
Mercury Spinal System DIA 5.5 x 30mm Straight Rod, Part Number: 60101-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080592 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1256-2013
Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod, Part Number: 60100-120. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080591 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1255-2013
Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod, Part Number: 60100-110. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080590 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1254-2013
Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod, Part Number: 60100-100. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080589 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1253-2013
Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod, Part Number: 60100-090. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080588 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1252-2013
Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod, Part Number: 60100-080. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080587 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1251-2013
Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod, Part Number: 60100-070. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot number: 080586 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1250-2013
Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod, Part Number: 60100-060. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080585 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1249-2013
Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod, Part Number: 60100-050. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080584 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1248-2013
Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod, Part Number: 60100-040. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080583 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1247-2013
Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod, Part Number: 60100-030. Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Lot Number: 080582 Class III Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue. 68 units total Z-1246-2013
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