Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0896-2026 — Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6006SP 12mm W X 12mm L, 6mm H, 5¿ Lord

U.S. FDA — Device Enforcement · United States · 2025-11-03 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0896-2026
Date of alert: 2025-11-03
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Orthofix U.S. LLC
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 18257200150151

Reported risk: Labeling contains claims that are not consistently present.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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