Recall Z-0907-2015 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Spinal Elements, Inc
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months non-operative treatment prior to being treated with this device.
| Date | Jan 5, 2015 (initiated Dec 18, 2014) |
| Status | Terminated |
| Reason | Spinal Elements is recalling the Ti-Bond related brochures that includes LT-10000 and MP-14000 (all revisions) the content regarding the Ti-Bond coating within the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. |
| Root cause | Labeling False and Misleading |
| Action | Spinal Elements sent an Urgent Field Action letter dated December 22, 2014, to all affected customers. The letter informed the customers to cease all distribution of the literature material. The letter informed the customers that the content regarding the Ti-Bond coating in the literature is unsubstantiated in context and/or misleading for the coating's use in spine applications. In addition to the customer notiification letter, it will include a list of claims related to the field action. The letter also informed customers of the actions to be taken. Customers were instructed to immediate |
| Quantity | 1200 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110632 | LUCENT OR LUCENT MAGNUM Spinal Elements, Inc., May 23, 2012 |