Home / Recalls / Orthopedic Alliance LLC / Z-1156-2013

Z-1156-2013 Class II Terminated

Recalled by Orthopedic Alliance LLC — Murrieta, CA

Recall Details

Product Type
Devices
Report Date
May 1, 2013
Initiation Date
March 7, 2013
Termination Date
March 26, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,300 units

Product Description

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.

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.

Distribution Pattern

Distributed in Texas.

Code Information

All lots are being recalled.

Other recalls by Orthopedic Alliance LLC

  • Z-1382-2013 Class II — Femoral head, standard, ¿26mm, +0mm Femoral head,medium, ¿26mm,+3mm Femoral he (February 20, 2013)
  • Z-1378-2013 Class II — Femoral component, CR, cemented, #1, left 2103-1310 Femoral component, CR, ceme (February 20, 2013)
  • Z-1384-2013 Class II — Co-Cr cancellous bone screw,15mm Co-Cr cancellous bone screw,20mm Co-Cr cancel (February 20, 2013)
  • Z-1379-2013 Class II — Tibial baseplate,cemented,#1 2203-3010 Tibial baseplate,cemented,#2 2203-3020 (February 20, 2013)
  • Z-1381-2013 Class II — U2 Acetabular cup, Ti beads porous coated, ¿44mm U2 Acetabular cup, Ti beads po (February 20, 2013)
  • Z-1385-2013 Class II — Zweimueller Type Stem SCS-Standard Sz 01 Zweimueller Type Stem SCS-Standard Sz (February 20, 2013)
  • Z-1383-2013 Class II — Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, O (February 20, 2013)
  • Z-1386-2013 Class II — Ball Head, 28 Short CERAMIC Ball Head, 28 Medium CERAMIC Ball Head, 28 Long CE (February 20, 2013)
  • Z-1380-2013 Class II — UKNEE Patella,small 2401-1010 UKNEE Patella,medium 2401-1020 UKNEE Patella,lar (February 20, 2013)