# FDA recall Z-0896-2026

> **Orthofix U.S. LLC** · Class III · device recall initiated 2025-11-03.

## Product

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¿ Lordotic  37-6006SP	12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6006SP	12mm W  X 12mm L, 6mm H, 5¿ Lordotic  37-6007SP	12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP	12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6007SP	12mm W  X 12mm L, 7mm H, 5¿ Lordotic  37-6008SP	12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP	12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6008SP	12mm W  X 12mm L, 8mm H, 5¿ Lordotic  37-6009SP	12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP	12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6009SP	12mm W  X 12mm L, 9mm H, 5¿ Lordotic  37-6010SP	12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP	12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6010SP	12mm W  X 12mm L, 10mm H, 5¿ Lordotic  37-6011SP	12mm W  X

## Reason for recall

Labeling contains claims that are not consistently  present.

## Distribution

Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR.

## Key facts

- **Recall number:** Z-0896-2026
- **Recalling firm:** Orthofix U.S. LLC
- **Classification:** Class III
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-03
- **Report date:** 2025-12-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lewisville, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0896-2026

## Citation

> AI Analytics. FDA recall Z-0896-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0896-2026. Source: US FDA. Licensed CC0.

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