FDADecember 18, 2014device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
spinal elementsspinal
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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