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Device Recall APLIF Implants and Instruments
Model / Serial
All lots are subject to this recall.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Nationwide Distribution including NV, WI, MD,and CA.
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.
Manufacturer
Spinal Solutions, LLC
1 Event
Recall of Device Recall APLIF Implants and Instruments
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Manufacturer
Spinal Solutions, LLC
Manufacturer Address
Spinal Solutions, LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
Source
USFDA
Language
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