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.

Inner pouch seal may be inadequate resulting in lack of sterility.

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.