FDA Device recall Z-0552-2021
PROKERA Slim, 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 Slim, 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-0552-2021 |
| 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 Slim, 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-PKS-14212,20-PKS-14213,20-PKS-14214,20-PKS-14215…Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PKS-14212,20-PKS-14213,20-PKS-14214,20-PKS-14215,20-PKS-14216,20-PKS-14217,20-PKS-14218,20-PKS-14219,20-PKS-14202,20-PKS-14203,20-PKS-14204,20-PKS-14205,20-PKS-14191,20-PKS-14192,20-PKS-14193,20-PKS-14194,20-PKS-14195,20-PKS-14196,20-PKS-14197,20-PKS-14198,20-PKS-14199,20-PKS-14200,20-PKS-14207,20-PKS-14208,20-PKS-14209,20-PKS-14210,20-PKS-14211,20-PKS-14206,20-PKS-14188,20-PKS-14189,20-PKS-14190,20-PKS-14201,20-PKS-14304,20-PKS-14272,20-PKS-14273,20-PKS-14274,20-PKS-14275,20-PKS-14276,20-PKS-14277,20-PKS-14290,20-PKS-14291,20-PKS-14292,20-PKS-14293,20-PKS-14294,20-PKS-14278,20-PKS-14279,20-PKS-14280,20-PKS-14297,20-PKS-14307,20-PKS-14308,20-PKS-14298,20-PKS-14309,20-PKS-14310,20-PKS-14311,20-PKS-14312,20-PKS-14313,20-PKS-14281,20-PKS-14282,20-PKS-14283,20-PKS-14284,20-PKS-14285,20-PKS-14286,20-PKS-14287,20-PKS-14288,20-PKS-14289,20-PKS-14305,20-PKS-14306,20-PKS-14295,20-PKS-14296,20-PKS-14314,20-PKS-14299,20-PKS-14 |
|---|
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-0552-2021%22
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