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.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: 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…
- Manufacturer
- Orthofix U.S. LLC
- Category
- Medical Device — Spinal implant
- Affected units
- 61,977
Distribution
Part of a larger recall action
This product is one of 6 recalled by Orthofix U.S. LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Orthofix U.S. LLC
See all →- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- ModerateOrthofix MINIRAIL External Fixation Devices Incorrectly Labeled
FDA (Devices) · 2026-07-22
- HighOrthofix MINIRAIL external fixation devices recalled for incorrect labeling
FDA (Devices) · 2026-07-22
- ModerateOrthofix Articulated Minirail Fixator devices recalled for incorrect labeling
FDA (Devices) · 2026-07-22
- ModerateFrozen surti undhiu mix recalled after testing positive for Salmonella
FDA (Devices) · 2025-12-17
Same hazard · labeling inconsistency
See all →- ModerateTitanium spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateSacroiliac fusion screws recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModerateTitanium spinal spacers recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- ModeratePTC spacer implants recalled over labeling claims not consistently present
FDA (Devices) · 2025-12-17
- SeverePTC spinal spacers recalled over labeling claims not consistently present
FDA (Food) · 2025-12-17
Similar recalls
- SeverePTC spinal spacers recalled over labeling claims not consistently present
FDA (Food) · 2025-12-17
- HighOrthofix Recalls Rival Plating Systems Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- ModerateOrthofix Pillar SA Ti Spacer System Mislabeled for Anterior Height
FDA (Devices) · 2025-04-02
- ModerateOrthofix MINIRAIL external fixation devices recalled for incorrect model labeling
FDA (Devices) · 2026-07-22
- HighOrthofix Rival Plating System Recalled Due to Screw Engagement Failure
FDA (Devices) · 2018-06-13
- ModerateMedtronic Endoskeleton TC Interbody System Recalled for Incorrect Size Labeling
FDA (Devices) · 2021-04-28