APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm...
FDA Device Recall #Z-1157-2013 — Class II — March 8, 2013
Recall Summary
| Recall Number | Z-1157-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | March 8, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Spinal Solutions, LLC |
| Location | Murrieta, CA |
| Product Type | Devices |
| Quantity | 220 units |
Product Description
APLIF Implants and Instruments, Part Numbers: 184008-10 Anterior Psoas Lumbar 18 x 40 x 08mm - 10degree 184010-10 Anterior Psoas Lumbar 18 x 40 x 10mm - 10degree 184012-10 Anterior Psoas Lumbar 18 x 40 x 12mm - 10degree 184014-10 Anterior Psoas Lumbar 18 x 40 x 14mm - 10degree 184016-10 Anterior Psoas Lumbar 18 x 40 x 16mm - 10degree 184008-00 Anterior Psoas Lumbar 18 x 40 x 08mm - 00degree 184010-00 Anterior Psoas Lumbar 18 x 40 x 10mm - 00degree 184012-00 Anterior Psoas Lumbar 18 x 40 x 12mm - 00degree 184014-00 Anterior Psoas Lumbar 18 x 40 x 14mm - 00degree 184016-00 Anterior Psoas Lumbar 18 x 40 x 16mm - 00degree 184510-08 Anterior Psoas Lumbar 18 x 45 x 08mm - 10degree 184510-10 Anterior Psoas Lumbar 18 x 45 x 10mm - 10degree 184512-10 Anterior Psoas Lumbar 18 x 45 x 12mm - 10degree 184514-10 Anterior Psoas Lumbar 18 x 45 x 14mm - 10degree 184516-10 Anterior Psoas Lumbar 18 x 45 x 16mm - 10degree 184510-00 Anterior Psoas Lumbar 18 x 45 x 10mm - 00degree 184512-00 Anterior Psoas Lumbar 18 x 45 x 12mm - 00degree 184514-00 Anterior Psoas Lumbar 18 x 45 x 14mm - 00degree 184516-00 Anterior Psoas Lumbar 18 x 45 x 16mm - 00degree 185008-10 Anterior Psoas Lumbar 18 x 50 x 08mm - 10degree 185010-10 Anterior Psoas Lumbar 18 x 50 x 10mm - 10degree 185012-10 Anterior Psoas Lumbar 18 x 50 x 12mm - 10degree 185014-10 Anterior Psoas Lumbar 18 x 50 x 14mm - 10degree 185016-10 Anterior Psoas Lumbar 18 x 50 x 16mm - 10degree 185008-00 Anterior Psoas Lumbar 18 x 50 x 08mm - 00degree 185010-00 Anterior Psoas Lumbar 18 x 50 x 10mm - 00degree 185012-00 Anterior Psoas Lumbar 18 x 50 x 12mm - 00degree 185014-00 Anterior Psoas Lumbar 18 x 50 x 14mm - 00degree 185016-00 Anterior Psoas Lumbar 18 x 50 x 16mm - 00degree 185508-10 Anterior Psoas Lumbar 18 x 55 x 08mm - 10degree 185510-10 Anterior Psoas Lumbar 18 x 55 x 10mm - 10degree 185512-10 Anterior Psoas Lumbar 18 x 55 x 12mm - 10degree 185514-10 Anterior Psoas Lumbar 18 x 55 x 14mm - 10degree 185516-10 Anterior Psoas Lumbar 18 x 55 x 16mm - 10degree 185508-00 Anterior Psoas Lumbar 18 x 55 x 08mm - 00degree 185510-00 Anterior Psoas Lumbar 18 x 55 x 10mm - 00degree 185512-00 Anterior Psoas Lumbar 18 x 55 x 12mm - 00degree 185514-00 Anterior Psoas Lumbar 18 x 55 x 14mm - 00degree 185516-00 Anterior Psoas Lumbar 18 x 55 x 16mm - 00degree The Eminent Spine Interbody Fusion System is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment.
Reason for Recall
Spinal Solutions is recalling the APLIF system because it 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, movement, or inadequate sterilization.
Distribution Pattern
Nationwide Distribution including NV, WI, MD,and CA.
Lot / Code Information
All lots are subject to this recall.
Other Recalls from Spinal Solutions, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1409-2013 | Class II | 45 mm Screw, Item #BG7045 Product Usage: Sp... | Feb 20, 2013 |
| Z-1411-2013 | Class II | Set Screw, Item #BG3010 Product Usage: Spin... | Feb 20, 2013 |
| Z-1418-2013 | Class II | Fang Screw 20mm Fang Plate 21mm Product Us... | Feb 20, 2013 |
| Z-1416-2013 | Class II | 14 x 11 x 6mm 7 deg 14 x 11 x 7mm 7 deg 14 ... | Feb 20, 2013 |
| Z-1415-2013 | Class II | 12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x ... | Feb 20, 2013 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.