# FDA recall Z-0551-2021

> **TissueTech, Inc.** · Class II · device recall initiated 2020-11-10.

## Product

PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

## Reason for recall

Potential exposure of product to microbial contamination.

## Distribution

US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.

## Key facts

- **Recall number:** Z-0551-2021
- **Recalling firm:** TissueTech, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-11-10
- **Report date:** 2020-12-16
- **Termination date:** 2023-07-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Doral, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2021

## Citation

> AI Analytics. FDA recall Z-0551-2021. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0551-2021. Source: US FDA. Licensed CC0.

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