# FDA recall Z-1501-2021

> **Nextremity Solutions** · Class II · device recall initiated 2021-03-26.

## Product

InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.

## Reason for recall

Product could potentially contain an undersized inner diameter of the 40mm drill bushing which result in not allowing the drill bit to pass through the drill bushing, causing inability of surgeon to complete surgical procedure as intended

## Distribution

AL, AK, CA, IA,IL, IN,  KY ,MD. MI, NJ, NY, OR, PA, SC, TX, VA

## Key facts

- **Recall number:** Z-1501-2021
- **Recalling firm:** Nextremity Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-03-26
- **Report date:** 2021-05-05
- **Termination date:** 2021-11-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1501-2021

## Citation

> AI Analytics. FDA recall Z-1501-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1501-2021. Source: US FDA. Licensed CC0.

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