ProgenaCare recalls progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2…

Recall date

April 18, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1137-2022

FDA classification

Class II

Brand / firm

ProgenaCare

Sold / distributed

US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.