Titan Spine Recalls Endoskeleton TA VBR Implants for Labeling Errors
Titan Spine is recalling 92 Endoskeleton TA VBR implants because their labels contain incorrect indications for use.
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 and involves a labeling error (incorrect indications for use) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Titan Spine, LLC is conducting a recall of 92 units of Endoskeleton TA VBR implants. The affected products include 18mm and 20mm Standard and Large Endoskeleton Implant VBR models, distributed nationwide including Nevada.
The recall is being conducted because the labeling accompanying the devices contains incorrect indications for use. The Endoskeleton TA VBR is intended for use in the thoracolumbar spine (T1-L5) to replace all or part of a collapsed, damaged, or unstable vertebral body due to tumor or trauma.
Healthcare providers and patients who have received these specific implants should contact Titan Spine, LLC for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Titan Spine Endoskeleton TA Implant products. 2107-0118 18mm Standard Endoskeleton Implant VBR 2107-0120 20mm Standard Endoskeleton Implant VBR 2107-0218 18mm Large Endoskeleton Implant VBR 2107-0220 20mm Large Endoskeleton Implant VBR Endoskeleton TA VBR is intended…
- Manufacturer
- TITAN SPINE, LLC
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 92
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 (9)
- Model # / Lot # 2107-0118: A110822
- A120907. 2107-0120 : A110812
- A110830
- A120263
- A120909. 2107-0218: A110813. 2107-0220: A110828
- A120262
- A120305
- A120801
- A120901.
Distribution
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