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

Recall Z-0891-2026 — Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H, Parallel; 37-3107SP 12mm W X 12mm L, 7mm H, Parallel; 37-3108SP 12mm W X 12mm L, 8mm H, Parallel; 37-3109SP 12mm W X 12mm L, 9mm H, Parallel;

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

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →

Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0891-2026
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): 18257200030590

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.

Related