# FDA recall Z-3178-2026

> **restor3d Inc.** · Class II · device recall initiated 2026-07-27.

## Product

Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

## Reason for recall

Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.

## Distribution

US Nationwide distribution in the states of FL, CO.

## Key facts

- **Recall number:** Z-3178-2026
- **Recalling firm:** restor3d Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-07-27
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3178-2026

## Citation

> MORVS. FDA recall Z-3178-2026. Retrieved 2026-10-24 from https://api.morvs.ai/recall/Z-3178-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*