Recall Z-1137-2022— ProgenaCare

Name: FDA recall Z-1137-2022
Creator: U.S. Food and Drug Administration
Published: 2022-04-18

Class II · Terminated

Class II FDA medical device recall by ProgenaCare, initiated 2022-04-18, terminated 2023-04-14. It names one FDA 510(k) clearance: K182010. Product: progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.. Reason: Inner pouch seal may be inadequate resulting in lack of sterility..

Recalling firm: ProgenaCare
Classification: Class II
Status: Terminated
Initiated: 2022-04-18
Terminated: 2023-04-14
Firm location: Marietta, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K182010 — ProgenaMatrixCell Constructs I, LLC·cleared 2019-01-17

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

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2 x 2 cm; (3) PM3004, 4 x 4 cm; PM3006, 6 x 6 cm; and PM3010, 10 x 10 cm.

Reason for recall

Inner pouch seal may be inadequate resulting in lack of sterility.

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