ModerateClass IITerminated

FDA Devices recall · Reported May 1, 2013

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 BGR0

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on May 1, 2013. Severity: Moderate. Recall number: Z-1156-2013.

Q: Where was the recalled product distributed?

Distribution: Distributed in Texas..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-1156-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 …

Recall #: Z-1156-2013
Affected scope: 3,300 units
Initiated: March 7, 2013

Reviewed by PlainRecalls Editorial, Product Recalls Editorial Team

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Orthopedic Alliance LLC recalled Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw … — a moderate-severity action.

Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw … was recalled by Orthopedic Alliance LLC in May 1, 2013. Reason: Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not s…. Check the official notice for the remedy. Verify recall #Z-1156-2013 with the FDA Devices before acting.

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The recall

Orthopedic Alliance LLC issued this moderate-severity FDA Devices recall — Orthopedic Alliance is recalling Blue & Gold Implants and Instruments because the Blue & Gold system is not s….

Moderate
severity level: 3K units
affected scope: Class II
classification: May 1, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1156-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1156-2013) was formally reported on May 1, 2013, with the manufacturer initiating the action on March 7, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Orthopedic Alliance LLC is listed as the recalling firm, operating out of Murrieta, CA. Federal records list the affected scope as 3,300 units.

The documented reason for this recall is: 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. … Distribution data in the federal record shows the product reached: Distributed in Texas.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

3,300 units

Related Recalls

6 from same agency

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1156-2013
Date reported	May 1, 2013
Date initiated	March 7, 2013
Recalling firm	Orthopedic Alliance LLC
Firm location	Murrieta, CA
Affected scope	3,300 units
Distribution	Distributed in Texas.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

3,300 units units affected — limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) —

Large-scale (100K – 1M units) —

Massive (≥1M units) —

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1156-2013) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting — recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on May 1, 2013. Severity: Moderate. Recall number: Z-1156-2013.

Where was the recalled product distributed? ▼

Distribution: Distributed in Texas..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-1156-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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What to do next

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Data Sources

Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported May 1, 2013.

Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.