Reported Jul 12, 2023 · Ongoing
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 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 FenestratedDermal Repair ScaffoldRx OnlySizes 10x25 cm20x25 cm4x4 cm6x6 cm8x12 cm8x8 cm
- Lot codes and dates
- Item No. (UDI-DI): 607-104-125(10381780113775) , 607-104-225 (10381780113782), 607-104-440 (10381780113560), 607-104-660 (10381780113577), 607-104-812 (10381780113768), 607-104-880 (10381780113584).
- Amount recalled
- 7,264 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.
Free recall alerts
Get alerted about new TEI Biosciences, Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.