Home / Recalls / Medical Devices
ProgenaCare recalls progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2
Recalled June 1, 2022 · FDA recall Z-1137-2022 · ProgenaCare
Hazard
Inner pouch seal may be inadequate resulting in lack of sterility. · FDA Class II
Units
547 packages
Sold at
US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.
Description
Inner pouch seal may be inadequate resulting in lack of sterility.
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.
Manufacturer(s)
ProgenaCare
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →