PriMatrix Ag Fenestrated dermal repair scaffolds recalled for endotoxin testing issues
TEI Biosciences recalled 7,264 units of PriMatrix Ag Fenestrated dermal repair scaffolds nationwide due to possible out-of-specification endotoxin test results caused by testing methodology defects.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall for a surgical product with a high-risk biological hazard (endotoxin). The source text does not report any illnesses, injuries, or hospitalizations, and the issue involves possible out-of-specification test results rather than confirmed contamination.
Plain-English summary
TEI Biosciences, Inc. has recalled PriMatrix Ag Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The issue stems from problems with in-process and finished goods endotoxin testing. A total of 7,264 units were distributed domestically across the United States in six size variants.
Endotoxins are bacterial toxins that can cause serious inflammatory and systemic reactions when introduced into the body. This recall affects healthcare providers and facilities that may have used the affected scaffold codes: 607-104-125, 607-104-225, 607-104-440, 607-104-660, 607-104-812, and 607-104-880.
The recalled product
- Product
- PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- endotoxin
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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).
Distribution
Distributed nationwide across the United States.
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