Spinal Solutions, LLC: Medical Device Recall in 2013 - (Recall #: Z-1157-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 8, 2013

Date Posted: May 1, 2013

Recall Number: Z-1157-2013

Event ID: 64578

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.

Status: Terminated

Product Quantity: 220 units

Code Information:

All lots are subject to this recall.

Distribution Pattern:

Nationwide Distribution including NV, WI, MD,and CA.

Voluntary or Mandated:

Voluntary: Firm initiated