Device product
PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Z-0550-2021
Product summary
- Firm
- TissueTech, Inc.
- Event
- Event 86807
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63 units
- Official record key
device-enforcement:Z-0550-2021
Official wording
Reason: Potential exposure of product to microbial contamination.
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
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.
Derived failure modes
-
Microbial contamination
microbial contamination