# FDA recall Z-0895-2026

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

## Product

Brand Name: Forza" Ti Spacer System  Product Name: Forza" Ti Spacer System  Model/Catalog Number: 38-2006SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H;  38-2007SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H;  38-2008SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H;  38-2009SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H;  38-2010SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H;  38-2011SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H;  38-2012SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H;  38-2013SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H;  38-2014SP	FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H;  38-2106SP	FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H;  38-2107SP	FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H;  38-2108SP	FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H;  38-2109SP	FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H;  38-2110SP	FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H;  38-2111SP	FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H;  38-2112SP	FORZA Ti Spacer, Straight, 0¿,

## 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-0895-2026
- **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-0895-2026

## Citation

> AI Analytics. FDA recall Z-0895-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0895-2026. Source: US FDA. Licensed CC0.

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