ProgenaCare Recall 90022
Description: 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 Recall 90022 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1137-2022 |
| Event ID | 90022 |
| Event Description | 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. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution. |
| Quantity | 547 packages |
| Recall Reason | Inner pouch seal may be inadequate resulting in lack of sterility. |
| Device Classification | 20220601 |
| Device Code Info | (1) Model PM2012, lot #02SEP21-001, exp. 4/9/2024; lot #29SEP21-001, exp. 4/9/2024. (2) Model PM3002, lot #28OCT21-001, exp. 3/7/2024. (3) Model PM3004, lot #02DEC21-001, exp. 10/1/2023; lot #02SEP21-002, exp. 10/1/2023; lot #14OCT21-001, exp. 10/1/2023; and 23NOV21-001, exp. 10/1/2023. (4) Model PM3006, lot #02SEP21-003, exp. 10/1/2023; lot #03DEC21-001, exp. 10/1/2023; lot #14OCT21-002, exp. 10/1/2023; and lot #23NOV21-002, exp. 10/1/2023. (5) Model PM3010, lot #13JUL21-001, exp. 10/1/2023; and lot #15JUL21-002, exp. 3/6/2024. |
| Center Classification Date | 20220526 |
| Recall Initiation Date | 20220418 |
| Recalling Firm | ProgenaCare |
| Initial Notification | Letter |
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