Z-1156-2013Class II

Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod...

Name: Z-1156-2013 Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod...
Creator: Orthopedic Alliance LLC
Published: 2013-03-07
License: https://open.fda.gov/license/

Orthopedic Alliance, LLC / initiated 2013-03-07 / Terminated / root cause: design

FDA source

Orthopedic Alliance LLC began a recall of 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... on 2013-03-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1156-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-07
Posted: 2013-04-22
Terminated: 2014-03-26
Recalling firm: Orthopedic Alliance, LLC
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.
Product code: MNI Orthosis, Spinal Pedicle Fixation
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.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: All lots are being recalled.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1156-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1156-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-22

Product code MNI

K033826Class IIOrthopedic Alliance Spine SystemOrthopedic Alliance, LLC / cleared 2004-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)