Orthopedic Alliance Spine System (alias "Blue & Gold") Part Numbers: BGC3010 Screw Cap BGR0040 Straight Rod 5.5 x 40mm B
FDA device recall Z-1156-2013 · posted 2013-04-22 · Terminated
Recall details
- Recalling firm
- Orthopedic Alliance LLC
- 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.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 3,300 units
- Distribution
- Distributed in Texas.
- Date initiated
- 2013-03-07
- Date posted
- 2013-04-22
- Date terminated
- 2014-03-26
- Location
- Murrieta, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ORTHOPEDIC ALLIANCE SPINE SYSTEM (K033826) | Orthopedic Alliance, LLC | 2004-07-01 |