Reported Jan 14, 2015 · Terminated
Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000, MP-14000 This device is intended to be used with autogenous…
Spinal Elements, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spinal Elements, Inc · 3115 Melrose Dr · Carlsbad, CA · 92010-6690
Is this the product you have?
- 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.
- Lot codes and dates
- All revisions
- Amount recalled
- 1200 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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