PROKERA Slim — Class II medical device recall Z-0552-2021
Terminated recall by TissueTech, Inc., reported 2020-12-16, distributed nationwide. Potential exposure of product to microbial contamination.
| Recall number | Z-0552-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | TissueTech, Inc., Doral, FL, United States |
| Recall initiated | 2020-11-10 |
| Classified | 2020-12-09 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2023-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 75 units |
| Reason classes | microbial contamination |
| Lot numbers | BTR192864, BTR192872, BTR193024, BTR194678 |
| Serial numbers | 20-PKS-14188, 20-PKS-14189, 20-PKS-14190, 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-14201, 20-PKS-14202, 20-PKS-14203, 20-PKS-14204, 20-PKS-14205, 20-PKS-14206, 20-PKS-14207, 20-PKS-14208, 20-PKS-14209, 20-PKS-14210, 20-PKS-14211, 20-PKS-14212 and 50 more |
Product
PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.
Reason for recall
Potential exposure of product to microbial contamination.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0552-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.