PriMatrix Dermal Scaffold Recalled Due to Endotoxin Testing Issues
TEI Biosciences is recalling 30,528 units of PriMatrix Fenestrated dermal repair scaffolds due to possible out-of-specification endotoxin test results. The FDA Class II recall affects wound healing products distributed nationwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 a Class II FDA recall for a medical device with endotoxin testing failures. Endotoxins are high-risk bacterial contaminants in medical devices, making this a risk-of-harm scenario. No illnesses or injuries have been reported, limiting the score per the rubric for theoretical hazards without confirmed harm.
Plain-English summary
PriMatrix Fenestrated is a dermal repair scaffold used in surgical and wound healing applications. The product is available in multiple sizes including 2x2 cm, 4x4 cm, 6x6 cm, 8x8 cm, 14mm and 18mm discs, and 10x25 cm meshed versions.
TEI Biosciences, Inc. is recalling 30,528 units due to possible out-of-specification endotoxin test results. Endotoxins are bacterial contaminants that can trigger serious adverse reactions if present on medical devices. The recall was triggered by issues identified in the company's in-process and finished goods endotoxin testing procedures.
Healthcare providers who have received affected units should contact TEI Biosciences for instructions on proper handling. The FDA is monitoring the recall.
The recalled product
- Product
- PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 30,528
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 (7)
- Item No. (UDI-DI): 607-004-440 (10381780113379)
- 607-004-660 (10381780113386)
- 607-004-880 (10381780113393)
- 607-005-014 (10381780357414)
- 607-005-018 (10381780357421)
- 607-005-125 (10381780113409)
- 607-005-220 (10381780357407).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 17 recalled by TEI Biosciences, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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