ProgenaCare: Medical Device Recall in 2022 - (Recall #: Z-1137-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product 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 Classification:

Class II

Date Initiated: April 18, 2022

Date Posted: June 1, 2022

Recall Number: Z-1137-2022

Event ID: 90022

Reason for Recall:

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

Status: Terminated

Product Quantity: 547 packages

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.

Distribution Pattern:

US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.

Voluntary or Mandated:

Voluntary: Firm initiated