FDA Medical Device Recalls (openFDA)
Spinal Solutions, LLC: 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.
- Recall number
- Z-1157-2013
- Recalling firm
- Spinal Solutions, LLC
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-03-08
- Posted
- 2013-04-22
- Terminated
- 2014-03-26
- Reason
- 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.
- Root cause
- No Marketing Application
- Action
- Spinal Solutions LLC sent an Urgent Medical Device Recall letter dated April 12, 2013, to all affected customers. The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to discontinue use of the affected product and return to the firm. Customers were also instructed to complete the bottom of the form and to return it by fax to (858) 764-9739. For questions regarding this recall call 951-304-9001.
- Quantity
- 220 units
- Distribution
- Nationwide Distribution including NV, WI, MD,and CA.
- Lot, serial or model codes
- All lots are subject to this recall.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MAX
- Firm FEI
- 3004884943
- Firm city
- Murrieta
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28