Doral, FL, United States
TissueTech, Inc. recalls
1 recall recorded since 2018, most recently on 10 November 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 10 November 2020
- Terminated
- 6 July 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0551-2021, Z-0550-2021, Z-0552-2021
- PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
- PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
- PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.