progenamatrix Human Keratin Matrix, sterile, Rx, with the following model numbers: (1) PM2012, 12 x 2 cm; (2) PM3002, 2
Summary
The FDA issued a Class II for progenamatrix Human Keratin Matrix, sterile, Rx, with the following model number by ProgenaCare. Reason: Inner pouch seal may be inadequate resulting in lack of sterility..
Details
Source
Device Recall
External ID
Z-1137-2022
Action Date
2022-06-01
Status
Terminated
Category
device
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.
Lot/Code Info: (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.
Quantity Affected: 547 packages
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-04-18
Company
Marietta, GA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 139 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ProgenaCare) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ProgenaCare have FDA actions?
This is the only FDA action we have on record for ProgenaCare in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1137-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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