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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold")

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  Class 2 Device Recall Orthopedic Alliance Spine System (alias "Blue & Gold") see related information
Date Initiated by Firm March 07, 2013
Date Posted April 22, 2013
Recall Status1 Terminated 3 on March 26, 2014
Recall Number Z-1156-2013
Recall Event ID 64584
510(K)Number K033826  
Product Classification Orthosis, spinal pedicle fixation - Product Code MNI
Product Orthopedic Alliance Spine System (alias "Blue & Gold")

Part Numbers:

BGC3010 Screw Cap
BGR0040 Straight Rod 5.5 x 40mm
BGR0050 Straight Rod 5.5 x 50mm
BGR0060 Straight Rod 5.5 x 60mm
BGR0070 Straight Rod 5.5 x 70mm
BGR0080 Straight Rod 5.5 x 80mm
BGR0090 Straight Rod 5.5 x 90mm
BGR0100 Straight Rod 5.5 x 100mm
BGR0110 Straight Rod 5.5 x 110mm
BGR0120 Straight Rod 5.5 x 120mm
BGR0130 Straight Rod 5.5 x 130mm
BGR0140 Straight Rod 5.5 x 140mm
BGR0150 Straight Rod 5.5 x 150mm
BGR0200 Straight Rod 5.5 x 200mm
BGR0300 Straight Rod 5.5 x 300mm
BGR0400 Straight Rod 5.5 x 400mm
BGR0500 Straight Rod 5.5 x 500mm
BGS5535 5.5 x 35mm Polyaxial Screw
BGS5540 5.5 x 40mm Polyaxial Screw
BGS5545 5.5 x 45mm Polyaxial Screw
BGS6035 6.0 x 35mm Polyaxial Screw
BGS6040 6.0 x 40mm Polyaxial Screw
BGS6045 6.0 x 45mm Polyaxial Screw
BGS6050 6.0 x 50mm Polyaxial Screw
BGS6535 6.5 x 35mm Polyaxial Screw
BGS6540 6.5 x 40mm Polyaxial Screw
BGS6545 6.5 x 45mm Polyaxial Screw
BGS6550 6.5 x 50mm Polyaxial Screw
BGS7035 7.0 x 35mm Polyaxial Screw
BGS7040 7.0 x 40mm Polyaxial Screw
BGS7045 7.0 x 45mm Polyaxial Screw
BGS7050 7.0 x 50mm Polyaxial Screw
BGS7055 7.0 x 55mm Polyaxial Screw
BGS7535 7.5 x 35mm Polyaxial Screw
BGS7540 7.5 x 40mm Polyaxial Screw
BGS7545 7.5 x 45mm Polyaxial Screw

A pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients.
Code Information All lots are being recalled.  
Recalling Firm/
Manufacturer		 Orthopedic Alliance LLC
26157 Jefferson Ave
Murrieta CA 92562-9561
For Additional Information Contact
909-304-9001
Manufacturer Reason
for Recall		 Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product peformance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
FDA Determined
Cause 2		 Device Design
Action A recall letter dated March 7, 2013 was sent to one customer who purchased the Blue & Gold Implants and instruments. The letter informed the customer that the Blue & Gold system is not supported by adequate testing and documentation to demonstrate that it meets performance or safety standards. These inadequacies might result in product performance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization. Customer is informed of the actions to be taken. Customer is instructed to complete the customer response form and return it by FAX to (858) 764-9739.
Quantity in Commerce 3,300 units
Distribution Distributed in Texas.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MNI and Original Applicant = ORTHOPEDIC ALLIANCE LLC
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