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U.S. Department of Health and Human Services

Class 2 Device Recall progenamatrix

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 Class 2 Device Recall progenamatrixsee related information
Date Initiated by FirmApril 18, 2022
Create DateMay 26, 2022
Recall Status1 Terminated 3 on April 14, 2023
Recall NumberZ-1137-2022
Recall Event ID 90022
510(K)NumberK182010 
Product Classification Dressing, wound, collagen - Product Code KGN
Productprogenamatrix 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.
Code Information (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.
Recalling Firm/
Manufacturer		 ProgenaCare
2275 Northwest Pkwy Se Ste 175
Marietta GA 30067-9321
For Additional Information ContactStacey Gray
770-627-2547
Manufacturer Reason
for Recall		Inner pouch seal may be inadequate resulting in lack of sterility.
FDA Determined
Cause 2		Employee error
ActionThe 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 Commerce547 packages
DistributionUS Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = KGN
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