# FDA recall Z-0892-2026

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

## Product

Brand Name: FORZA" PTC Spacer System  Product Name: FORZA" PTC Spacer System  Model/Catalog Number: 38-1007SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H  38-1008SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H;  38-1009SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H;  38-1010SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H;  38-1011SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H;  38-1012SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H;  38-1013SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H;  38-1014SP	FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H;  38-1707SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H;  38-1708SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H;  38-1709SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H;  38-1710SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H;  38-1711SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H;  38-1712SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H;  38-1713SP	FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H;  38-1714SP	FORZA PTC Spacer, Curved, 

## 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-0892-2026
- **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-0892-2026

## Citation

> AI Analytics. FDA recall Z-0892-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0892-2026. Source: US FDA. Licensed CC0.

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