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U.S. Department of Health and Human Services

Class 2 Device Recall APLIF Implants and Instruments

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 Class 2 Device Recall APLIF Implants and Instruments see related information
Date Posted April 22, 2013
Recall Status1 Terminated on March 26, 2014
Recall Number Z-1157-2013
Recall Event ID 64578
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
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.
Code Information All lots are subject to this recall.
Recalling Firm/
Manufacturer
Spinal Solutions, LLC
26157 Jefferson Ave
Murrieta CA 92562-9561
For Additional Information Contact
951-304-9001
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 220 units
Distribution Nationwide Distribution including NV, WI, MD,and CA.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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