Orthopedic Alliance Recalls Blue & Gold Spine System Implants
Orthopedic Alliance LLC is recalling Blue & Gold Spine System implants and instruments because the system lacks adequate testing and documentation to demonstrate it meets performance or safety standards.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II, and the source text explicitly states that product performance failures could cause patient harm due to implant breakage, loosening, or inadequate sterilization, which aligns with the rubric criteria for Severe severity.
Plain-English summary
Orthopedic Alliance LLC is recalling the Blue & Gold Spine System, a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients. The recall includes various part numbers for screw caps, straight rods, and polyaxial screws. Approximately 3,300 units were distributed in Texas.
The recall was initiated 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 performance failures that could cause patient harm due to implant breakage, loosening, or inadequate sterilization.
The FDA has classified this recall as Class II. Consumers and healthcare providers should contact Orthopedic Alliance LLC for further instructions on how to proceed with the recalled devices.
The recalled product
- 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
- Manufacturer
- Orthopedic Alliance LLC
- Affected units
- 3,300
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots are being recalled.
Distribution
Distributed in 1 state:
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