progenamatrix Human Keratin Matrix — Class II medical device recall Z-1137-2022
Terminated recall by ProgenaCare, reported 2022-06-01, distributed nationwide. Inner pouch seal may be inadequate resulting in lack of sterility.
| Recall number | Z-1137-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ProgenaCare, Marietta, GA, United States |
| Recall initiated | 2022-04-18 |
| Classified | 2022-05-26 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2023-04-14 |
| Distributed | Nationwide (US) |
| Quantity | 547 packages |
| Reason classes | sterility, packaging |
| Lot numbers | 02DEC21-001, 02SEP21-001, 02SEP21-002, 02SEP21-003, 03DEC21-001, 13JUL21-001, 14OCT21-001, 14OCT21-002, 15JUL21-002, 23NOV21-001, 23NOV21-002, 28OCT21-001, 29SEP21-001 |
| Model numbers | PM2012, PM3002, PM3004, PM3006, PM3010 |
| Expiration dates | 2023-10-01, 2024-03-06, 2024-03-07, 2024-04-09 |
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.
Reason for recall
Inner pouch seal may be inadequate resulting in lack of sterility.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1137-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.