# FDA recall Z-1027-2022

> **restor3d Inc.** · Class II · device recall initiated 2022-03-30.

## Product

Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018).  Orthopedic manual surgical instrument

## Reason for recall

During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.

## Distribution

US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.

## Key facts

- **Recall number:** Z-1027-2022
- **Recalling firm:** restor3d Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-03-30
- **Report date:** 2022-05-11
- **Termination date:** 2023-08-28

- **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-1027-2022

## Citation

> AI Analytics. FDA recall Z-1027-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1027-2022. Source: US FDA. Licensed CC0.

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