# FDA recall Z-1137-2022

> **ProgenaCare** · Class II · device recall initiated 2022-04-18.

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1137-2022
- **Recalling firm:** ProgenaCare
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-04-18
- **Report date:** 2022-06-01
- **Termination date:** 2023-04-14

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marietta, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1137-2022

## Citation

> AI Analytics. FDA recall Z-1137-2022. Retrieved 2026-07-28 from https://api.ai-analytics.org/recall/Z-1137-2022. Source: US FDA. Licensed CC0.

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