Home / Recalls / TissueTech, Inc. / Z-0550-2021

Z-0550-2021 Class II Terminated

Recalled by TissueTech, Inc. — Doral, FL

Recall Details

Product Type
Devices
Report Date
December 16, 2020
Initiation Date
November 10, 2020
Termination Date
July 6, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
63 units

Product Description

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

Reason for Recall

Potential exposure of product to microbial contamination.

Distribution Pattern

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.

Code Information

Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PK16-00761,20-PK16-00762,20-PK16-00763,20-PK16-00767,20-PK16-00796,20-PK16-00797,20-PK16-00798,20-PK16-00803,20-PK16-00815,20-PK16-00816,20-PK16-00817,20-PK16-00818,20-PK16-00819,20-PK16-00759,20-PK16-00760,20-PK16-00808,20-PK16-00809,20-PK16-00781,20-PK16-00820,20-PK16-00791,20-PK16-00792,20-PK16-00804,20-PK16-00805,20-PK16-00806,20-PK16-00807,20-PK16-00810,20-PK16-00811,20-PK16-00812,20-PK16-00813,20-PK16-00814,20-PK16-00768,20-PK16-00769,20-PK16-00782,20-PK16-00783,20-PK16-00778,20-PK16-00770,20-PK16-00771,20-PK16-00772,20-PK16-00773,20-PK16-00774,20-PK16-00775,20-PK16-00776,20-PK16-00777,20-PK16-00765,20-PK16-00779,20-PK16-00780,20-PK16-00799,20-PK16-00800,20-PK16-00793,20-PK16-00794,20-PK16-00795,20-PK16-00784,20-PK16-00785,20-PK16-00801,20-PK16-00764,20-PK16-00821,20-PK16-00789,20-PK16-00790,20-PK16-00766,20-PK16-00786,20-PK16-00787,20-PK16-00788, and 20-PK16-00802

Other recalls by TissueTech, Inc.

  • Z-0551-2021 Class II — PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage. (November 10, 2020)
  • Z-0552-2021 Class II — PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage. (November 10, 2020)