Orthofix U.S. LLC recalls FIREBIRD SI Fusion System screws due to inconsistent labeling. Affected models include 11mm and 12mm screws with specific catalog numbers. No action required as labeling issues do not pose safety risks.
Labeling contains claims that are not consistently present.
Orthofix U.S. LLC is recalling FIREBIRD SI Fusion System screws (model numbers 18-1025SP to 18-2070SP) because their labeling claims are not consistently present. This labeling issue does not pose a safety risk, so no action is needed.
The labeling inconsistency means some product information may not be clearly visible. However, this does not affect the physical safety of the screws themselves.
Orthofix U.S. LLC's FIREBIRD SI Fusion System screws (11mm and 12mm sizes) are used in medical implants. Patients with these screws are not at risk of injury from the labeling issue.
Check for model numbers 18-1025SP through 18-2070SP on the screw packaging or product labels. These screws are used in medical implants and have specific sizes (11mm and 12mm).
Review the product label for consistent labeling claims. If inconsistent, contact Orthofix U.S. LLC for more information.
No action is required. The labeling issue does not pose a safety risk.
The affected models are 11mm and 12mm FIREBIRD SI screws with catalog numbers 18-1025SP to 18-2070SP.
No. The labeling inconsistency does not affect the physical safety of the screws.
We’ve drafted a message you can send FIREBIRD to request your refund or repair — edit it as you like.
Subject: Recall Z-0894-2026 — FIREBIRD FIREBIRD Hello, I own a FIREBIRD that is covered by recall Z-0894-2026 from FIREBIRD. 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.
