FDA-Device2022-06-01Class II
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.
ProgenaCare
Hazard
Inner pouch seal may be inadequate resulting in lack of sterility.
Sold states
US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.
Affected count
547 packages
Manufactured in
2275 Northwest Pkwy Se Ste 175, Marietta, GA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2022Don't want to check this manually?
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