# FDA recall Z-0891-2026

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

## Product

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;  37-3110SP	12mm W  X 12mm L, 10mm H, Parallel;  37-3111SP	12mm W  X 12mm L, 11mm H, Parallel;  37-3112SP	12mm W  X 12mm L, 12mm H, Parallel;  37-3113SP	12mm W  X 12mm LW, 13mm H, Parallel;  37-3114SP	12mm W  X 12mm WL, 14mm H, Parallel;  37-3006SP	12mm W X 12mm L, 6mm H, 5¿ Lordotic;  37-3007SP	12mm W X 12mm L, 7mm H, 5¿ Lordotic;  37-3008SP	12mm W X 12mm L, 8mm H, 5¿ Lordotic;  37-3009SP	12mm WL X 12mm L, 9mm H, 5¿ Lordotic;  37-3010SP	12mm W X 12mm L, 10mm H, 5¿ Lordotic;  37-3011SP	12mm W X 12mm L, 11mm H, 5¿ Lordotic;  37-3012SP	12mm W X 12mm L, 12mm H, 5¿ Lordotic;  37-3013SP	12mm W X 12mm L, 13mm H, 5¿ Lordotic;  37-3014SP	12mm W X 12mm L, 14mm H, 5¿ Lordotic;  37-3207SP	12mm W X 12mm L

## 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-0891-2026
- **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-0891-2026

## Citation

> AI Analytics. FDA recall Z-0891-2026. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0891-2026. Source: US FDA. Licensed CC0.

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