Mini PTC spacer implants recalled over labeling claims not consistently present
Orthofix U.S. is recalling 61,977 CONSTRUX Mini PTC 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 PTC Spacer System from Orthofix U.S. LLC is being recalled, across a range of catalog numbers listed in the enforcement record including 37-3106SP, 37-3107SP and 37-3108SP, 12mm width by 12mm length parallel spacers with heights of 6mm, 7mm and 8mm.
The reason given in the enforcement record is that the labeling contains claims that are not consistently present.
The record lists 61,977 units across all lots. Distribution was worldwide, including nationwide in the United States. 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 PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L
- 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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