Orthofix U.S. LLC recalls Pillar SA PTC Spacer Systems with inconsistent labeling. Affected models include 39-9012SP to 39-2218SP. No remedy specified in recall notice.
Labeling contains claims that are not consistently present.
Orthofix U.S. LLC is recalling Pillar SA PTC Spacer Systems due to 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 products, which could lead to user confusion. However, this does not involve physical hazards or safety risks.
Users of Pillar SA PTC Spacer Systems with model numbers 39-9012SP through 39-2218SP are affected. Patients receiving spinal implants are most at risk of confusion.
Check for model numbers 39-9012SP through 39-2218SP on the product. These models were sold with inconsistent labeling claims.
Verify if your Pillar SA PTC Spacer System has inconsistent labeling claims as described in the recall notice.
No, the recall is for inconsistent labeling claims only, which does not pose a safety risk.
Models 39-9012SP through 39-2218SP with inconsistent labeling claims.
The recall does not require any action; users should check for inconsistent labeling claims.
We’ve drafted a message you can send Pillar to request your refund or repair — edit it as you like.
Subject: Recall Z-0893-2026 — Pillar Pillar Hello, I own a Pillar that is covered by recall Z-0893-2026 from Pillar. 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.