# FDA recall Z-0893-2026

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

## Product

Brand Name: Pillar" SA PTC Spacer System  Product Name: Pillar" SA PTC Spacer System  Model/Catalog Number: 39-9012SP	33W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-9014SP	33W X 28L X 14H, 7DEG PTC IMPLANT;  39-9016SP	33W X 28L X 16H, 7DEG PTC IMPLANT;  39-9018SP	33W X 28L X 18H, 7DEG PTC IMPLANT;  39-9212SP	33W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-9214SP	33W X 28L X 14H, 12DEG PTC IMPLANT;  39-9216SP	33W X 28L X 16H, 12DEG PTC IMPLANT;  39-9218SP	33W X 28L X 18H, 12DEG PTC IMPLANT;  39-2012SP	37W X 28L X 12.5H, 7DEG PTC IMPLANT;  39-2014SP	37W X 28L X 14H, 7DEG PTC IMPLANT;  39-2016SP	37W X 28L X 16H, 7DEG PTC IMPLANT;  39-2018SP	37W X 28L X 18H, 7DEG PTC IMPLANT;  39-2212SP	37W X 28L X 12.5H, 12DEG PTC IMPLANT;  39-2214SP	37W X 28L X 14H, 12DEG PTC IMPLANT;  39-2216SP	37W X 28L X 16H, 12DEG PTC IMPLANT;  39-2218SP	37W X 28L X 18H, 12DEG PTC IMPLANT;

## 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-0893-2026
- **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-0893-2026

## Citation

> AI Analytics. FDA recall Z-0893-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0893-2026. Source: US FDA. Licensed CC0.

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