Dermal Repair Scaffold Recalled Due to Endotoxin Testing Issues
TEI Biosciences is recalling PriMatrix Meshed dermal repair scaffolds due to endotoxin testing failures. The recall affects 33,277 units 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: FDA Class II medical device recall involving endotoxin testing procedures. Although no illnesses or injuries have been reported and there is no confirmed endotoxin contamination, the testing failures create genuine uncertainty about device safety standards, meeting the rubric criteria for a risk-of-harm product without reported injuries.
Plain-English summary
PriMatrix Meshed, a prescription dermal repair scaffold manufactured by TEI Biosciences, Inc., is being recalled due to problems with endotoxin testing. The recall affects 33,277 units that were distributed nationwide in the United States.
The FDA identified issues with the manufacturer's in-process and finished goods endotoxin testing procedures. Because of these testing problems, endotoxin test results for affected units may be out of specification, meaning there is uncertainty about whether the devices meet required safety standards for endotoxin contamination.
Endotoxins are bacterial substances that can trigger inflammatory and immune responses in patients. Although no illnesses or injuries have been reported in relation to this recall, the testing failures create uncertainty about the safety of the affected devices.
The recalled product
- Product
- PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 33,277
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): 607-005-225 (10381780113423)
- 607-005-330 (10381780113430)
- 607-005-440 (10381780113447)
- 607-005-550 (10381780113454)
- 607-005-660 (10381780113461)
- 607-005-812 (10381780113478)
- 607-005-880 (10381780113485).
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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