Spinal Elements Recalls Ti-Bond Marketing Literature Due to Misleading Claims
Spinal Elements is recalling Ti-Bond marketing literature because the content regarding the Ti-Bond coating is unsubstantiated and misleading for spine applications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves misleading marketing claims rather than a direct physical defect or reported injury, fitting the criteria for moderate severity involving labeling or documentation issues.
Plain-English summary
Spinal Elements, Inc. is recalling 1,200 units of Ti-Bond Marketing Literature/Labeling, Catalog No. LT10000 and MP-14000, all revisions. The product was distributed nationwide.
The recall was initiated because 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. The device is intended to be used with autogenous bone graft, and patients must have undergone a regimen of at least six months of non-operative treatment prior to being treated with this device.
No specific instructions for consumers are provided in the source text beyond the recall of the literature itself.
The recalled product
- 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
- Spinal Elements, Inc
- Hazard
- Affected units
- 1,200
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All revisions
Distribution
Distributed nationwide across the United States.
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