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.
What this means for you
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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