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.
Reported: June 1, 2022 Initiated: April 18, 2022 #Z-1137-2022
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.
Reason for Recall
Inner pouch seal may be inadequate resulting in lack of sterility.
Details
- Recalling Firm
- ProgenaCare
- Units Affected
- 547 packages
- Distribution
- US Nationwide distribution in the states of AL, GA, FL, TN, and TX. There was no foreign/military/government distribution.
- Location
- Marietta, GA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ProgenaCare. Units affected: 547 packages.
Why was this product recalled? ▼
Inner pouch seal may be inadequate resulting in lack of sterility.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 1, 2022. Severity: Moderate. Recall number: Z-1137-2022.
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