Home / Recalls / Medical Devices
Spinal Elements, Inc recalls Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous
Recalled January 14, 2015 · FDA recall Z-0907-2015 · Spinal Elements
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. · FDA Class II
Units
1200 units
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Spinal Elements, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →