Reported Jul 12, 2023 · Ongoing
PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm…
TEI Biosciences, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TEI Biosciences, Inc. · 7 Elkins St · Boston, MA · 02127-1601
Is this the product you have?
- PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only
- Sizes 10x12 cm (2
1)10x25
- cm (2
1)20x25
- cm (1
1)4x4
- cm (2
1)6x6
- cm (2
1)8x12
- cm (2
1)8x8
- cm (21)
- Lot codes and dates
- Item No. (UDI-DI): 607-105-112 (10381780177685), 607-105-125 (10381780113591), 607-105-225 (10381780113607), 607-105-440 (10381780113614), 607-105-660 (10381780177715), 607-105-812 (10381780177739), 607-105-880 (10381780177722).
- Amount recalled
- 10,159 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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