# FDA recall Z-1127-2020

> **Nextremity Solutions** · Class II · device recall initiated 2019-12-16.

## Product

Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.

## Reason for recall

The product contains a different plate than indicated by the package labeling. The product is labeled as a right plate but contains a left plate.

## Distribution

Domestic distribution to AL, CA, FL, GA, ID, IL, IA, KY, LA, ME, MA, MI, MN, MS, NE, NJ, NY, OH ,OK, OR, TX, and WA.

## Key facts

- **Recall number:** Z-1127-2020
- **Recalling firm:** Nextremity Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-16
- **Report date:** 2020-02-19
- **Termination date:** 2020-09-08

- **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-1127-2020

## Citation

> AI Analytics. FDA recall Z-1127-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1127-2020. Source: US FDA. Licensed CC0.

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