Orthofix U.S. LLC recalls CONSTRUX Mini Ti Spacer System (models 37-6005SP to 37-9312SP) due to inconsistent labeling claims. No remedy specified in recall notice.
Labeling contains claims that are not consistently present.
Orthofix U.S. LLC is recalling CONSTRUX Mini Ti Spacer Systems with inconsistent labeling claims. This issue does not pose a safety risk but may cause confusion for users.
The labeling claims are not consistently present across all units, which could lead to confusion about product specifications. However, this does not involve physical hazards or safety risks.
Users of CONSTRUX Mini Ti Spacer Systems for spinal or orthopedic applications. Most at risk are those who rely on precise labeling for medical use.
Check for CONSTRUX Mini Ti Spacer Systems with model numbers 37-6005SP through 37-9312SP. All units sold with these model numbers are affected.
Verify if the product label shows consistent claims for the specific model.
No, the recall is for inconsistent labeling claims only, not a safety hazard.
No, the recall does not require stopping use; it's about labeling clarity.
The recall notice does not specify a remedy, so no action is required beyond checking labeling consistency.
We’ve drafted a message you can send CONSTRUX to request your refund or repair — edit it as you like.
Subject: Recall Z-0896-2026 — CONSTRUX CONSTRUX Hello, I own a CONSTRUX that is covered by recall Z-0896-2026 from CONSTRUX. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
