# FDA recall Z-1629-2026

> **Orthalign, Inc** · Class II · device recall initiated 2026-02-10.

## Product

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5  REF:402566  component Lantern Knee System

## Reason for recall

Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)

## Distribution

US Nationwide distribution in the state of UT.

## Key facts

- **Recall number:** Z-1629-2026
- **Recalling firm:** Orthalign, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-02-10
- **Report date:** 2026-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Aliso Viejo, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1629-2026

## Citation

> AI Analytics. FDA recall Z-1629-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1629-2026. Source: US FDA. Licensed CC0.

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