Z-1137-2022Class II

progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2)...

Name: Z-1137-2022 progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2)...
Creator: ProgenaCare
Published: 2022-04-18
License: https://open.fda.gov/license/

ProgenaCare / initiated 2022-04-18 / Terminated / root cause: manufacturing process

FDA source

ProgenaCare began a recall of 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... on 2022-04-18. FDA classified it as Class II and gives the reason as "Inner pouch seal may be inadequate resulting in lack of sterility". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1137-2022
Classification: Class II
Status: Terminated
Initiated: 2022-04-18
Posted: 2022-05-26
Terminated: 2023-04-14
Recalling firm: ProgenaCare
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.
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: Inner pouch seal may be inadequate resulting in lack of sterility.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 547 packages
Distribution: US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.
Product codes and lots: (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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1137-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1137-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-26

Product code KGN

K182010UnclassifiedProgenaMatrixCell Constructs I, LLC / cleared 2019-01-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)