FDA Device recall Z-0551-2021
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage by Tissuetech, citing potential exposure of product to microbial contamination.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0551-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-10 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Tissuetech |
| Distribution | US |
Product
PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Reason
Potential exposure of product to microbial contamination.
Identifiers
| code_info | Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990…Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990,20-PKP-00991,20-PKP-00992,20-PKP-00993,20-PKP-00995,20-PKP-00996, and 20-PKP-00997 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0551-2021%22
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