Orthofix U.S. recalled 61,977 units of the CONSTRUX Mini PTC Spacer System on November 3, 2025. The recall impacts various model numbers due to inconsistent labeling claims. Consumers should stop using the product immediately and follow manufacturer instructions for a refund.
Labeling contains claims that are not consistently present.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthofix U.S. LLC or your healthcare provider for instructions. Notification method: E-Mail
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The recall includes the CONSTRUX Mini PTC Spacer System with model numbers 37-3106SP through 37-5212SP. The products measure 12mm or 15mm in width and vary in height from 6mm to 14mm. These devices were distributed worldwide, including across the United States and several countries.
The recall stems from labeling that contains inconsistent claims. This issue can lead to improper usage of the device, potentially affecting patient safety.
No injuries or incidents related to this recall have been reported so far. The hazard level is classified as high due to the potential consequences of incorrect usage.
Consumers and healthcare providers should stop using the device immediately. Follow the recall instructions from Orthofix U.S. and contact your healthcare provider for further guidance.
For more information, contact Orthofix U.S. LLC via email or visit their website. Additional details can be found on the FDA's recall page.
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