Recall Z-1157-2013 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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 184
| Date | Apr 22, 2013 (initiated Mar 8, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.