Titanium spinal spacers recalled over labeling claims not consistently present
Orthofix U.S. is recalling 40,956 CONSTRUX Mini Ti Spacer System units because the labeling contains claims that are not consistently present.
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: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites inconsistent labeling claims with no stated product defect or consequence.
Plain-English summary
The CONSTRUX Mini Ti Spacer System from Orthofix U.S. LLC is being recalled, across a range of catalog numbers and sizes listed in the enforcement record, including 37-6005SP, 37-6006SP, 37-6007SP, 37-6008SP and 37-6009SP in 12mm width by 12mm length with heights from 5mm to 9mm.
The reason given in the enforcement record is that the labeling contains claims that are not consistently present.
The record lists 40,956 units across all lot codes. Distribution was worldwide, including nationwide in the United States and Puerto Rico, and to Australia, Germany, the United Kingdom, Hungary, the Czech Republic, Canada and Chile. The FDA has classified the action as Class III, its least serious category.
The record describes an inconsistency in labeling claims rather than a product defect, and states no injuries. Facilities should follow Orthofix's instructions.
The recalled product
- Product
- Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12
- Manufacturer
- Orthofix U.S. LLC
- Category
- Medical Device — Spinal implant
- Hazard
- labeling-inconsistency
- spinal-implant
- class-iii
Distribution
Distributed nationwide across the United States.
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