FDA-Device2015-01-14Class II
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.
Spinal Elements, Inc
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.
Sold states
Nationwide Distribution
Affected count
1200 units
Manufactured in
3115 Melrose Dr, Suite 200, Carlsbad, CA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0907-2015Don't want to check this manually?
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