FDA recall Z-1137-2022

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 for recall

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

Distribution

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

Key facts

Status

Terminated

Initiation date

2022-04-18

Report date

2022-06-01

Termination date

2023-04-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Marietta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2022