Progenamatrix Keratin Matrix (ProgenaCare) – sterility concern (2022)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
ProgenaCare
Lot Codes / Batch Numbers
(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.
Products Sold
(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.
ProgenaCare is recalling progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x due to Inner pouch seal may be inadequate resulting in lack of sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inner pouch seal may be inadequate resulting in lack of sterility.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 4/18/2022 via FedEx on 4/18/2022 for all but one consignee, who was hand-delivered the letter on 4/20/2022. The letter identified the product and requested the consignee immediately check their inventory for the affected product and quarantine it prior to return. The consignee is requested to forward the recall notification to any customers who were distributed the product and request it be returned. The consignee was requested to contact the recalling firm by email no later than 4/30/2022 to confirm receipt of the letter and to obtain a Return Materials Authorization for any units in their inventory. A reply card was also enclosed should the consignee rather mail their response to the recalling firm. The reply card asked if they have any recalled product in inventory, have they distributed any of it, and requests their customers are notified of the recall.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026