Orthofix recalls CONSTRUX Mini PTC Spacer Systems with inconsistent labeling claims. Affected models include various sizes and lordotic angles. No action needed as labeling issues don't pose safety risks.
Labeling contains claims that are not consistently present.
Orthofix is recalling CONSTRUX Mini PTC Spacer Systems due to inconsistent labeling claims across different models. This labeling issue does not pose a safety risk to users.
The labeling claims are not consistently present across the product models, which could lead to confusion about the device's specifications. However, this labeling inconsistency does not cause physical harm or safety risks during normal use.
Users of CONSTRUX Mini PTC Spacer Systems with the listed model numbers and lot codes. Patients using these devices for spinal support are most at risk if they rely on labeling for correct usage.
Check for model numbers starting with 37- or 47- followed by SP and a specific size (e.g., 37-3106SP). Also look for lot codes listed in the recall notice.
Review the product label for consistent labeling claims as described in the recall notice.
No action is needed. The labeling inconsistency does not pose a safety risk, so users can continue using the product as normal.
Affected models include 37-3106SP through 37-5212SP with specific sizes and lordotic angles as listed in the recall notice.
No. The labeling inconsistency does not cause physical harm or safety risks during normal use.
We’ve drafted a message you can send CONSTRUX to request your refund or repair — edit it as you like.
Subject: Recall Z-0891-2026 — CONSTRUX CONSTRUX Hello, I own a CONSTRUX that is covered by recall Z-0891-2026 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.
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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.
