Recall Z-0552-2021— TissueTech, Inc.

Name: FDA recall Z-0552-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-10

Class II · Terminated

Class II FDA medical device recall by TissueTech, Inc., initiated 2020-11-10, terminated 2023-07-06. It names one FDA 510(k) clearance: K032104. Product: PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.. Reason: Potential exposure of product to microbial contamination..

Recalling firm: TissueTech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-10
Terminated: 2023-07-06
Firm location: Doral, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K032104 — AMNIOLENSBio-Tissue, Inc.·cleared 2003-12-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Potential exposure of product to microbial contamination.

Data sourced from openFDA. This site is unofficial and independent of the FDA.