Marietta, GA, United States
ProgenaCare recalls
1 recall recorded since 2018, most recently on 18 April 2022. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 18 April 2022
- Terminated
- 14 April 2023
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1137-2022
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.