# FDA recall Z-0894-2026

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

## Product

Brand Name: FIREBIRD" SI Fusion System  Product Name: FIREBIRD" SI Fusion System  Model/Catalog Number: 18-1025SP	11mm X 25mm FIREBIRD SI Screw;  18-1030SP	11mm X 30mm FIREBIRD SI Screw;  18-1035SP	11mm X 35mm FIREBIRD SI Screw;  18-1040SP	11mm X 40mm FIREBIRD SI Screw;  18-1045SP	11mm X 45mm FIREBIRD SI Screw;  18-1050SP	11mm X 50mm FIREBIRD SI Screw;  18-1055SP	11mm X 55mm FIREBIRD SI Screw;  18-1060SP	11mm X 60mm FIREBIRD SI Screw;  18-1065SP	11mm X 65mm FIREBIRD SI Screw;  18-1070SP	11mm X 70mm FIREBIRD SI Screw;  18-2025SP	12mm X 25mm FIREBIRD SI Screw;  18-2030SP	12mm X 30mm FIREBIRD SI Screw;  18-2035SP	12mm X 35mm FIREBIRD SI Screw;  18-2040SP	12mm X 40mm FIREBIRD SI Screw;  18-2045SP	12mm X 45mm FIREBIRD SI Screw;  18-2050SP	12mm X 50mm FIREBIRD SI Screw;  18-2055SP	12mm X 55mm FIREBIRD SI Screw;  18-2060SP	12mm X 60mm FIREBIRD SI Screw;  18-2065SP	12mm X 65mm FIREBIRD SI Screw;  18-2070SP	12mm X 70mm FIREBIRD SI Screw

## 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-0894-2026
- **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-0894-2026

## Citation

> AI Analytics. FDA recall Z-0894-2026. Retrieved 2026-07-05 from https://api.ai-analytics.org/recall/Z-0894-2026. Source: US FDA. Licensed CC0.

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