Dermal repair scaffold recalled due to endotoxin testing failures
TEI Biosciences is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds due to testing failures that cannot verify endotoxin levels. Procedures for testing bacterial toxin levels during manufacturing quality control were found to be flawed.
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 classification for a tissue-contact medical device with potential endotoxin contamination, which can cause inflammatory reactions. No illnesses or injuries reported; contamination is unconfirmed due to testing failure. Meets rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
TEI Biosciences, Inc. is recalling 10,159 units of PriMatrix Ag Meshed dermal repair scaffolds nationwide due to issues with endotoxin testing procedures. The company identified problems with both in-process and finished-goods endotoxin testing that prevent verification that products meet safety specifications.
PriMatrix Ag Meshed is a prescription medical device used as a dermal repair scaffold for wound care and skin repair. The product is available in seven sizes ranging from 4x4 cm to 20x25 cm. Endotoxins are bacterial toxins that can cause inflammatory reactions if present in medical devices that contact tissue.
Because the endotoxin testing procedures were flawed, the company cannot confirm that distributed units contain safe endotoxin levels. No illnesses or injuries have been reported to date. Affected facilities should discontinue use and contact the manufacturer for instructions on device replacement or disposal.
Affected units can be identified by Item Number (UDI-DI) codes: 607-105-112, 607-105-125, 607-105-225, 607-105-440, 607-105-660, 607-105-812, or 607-105-880.
The recalled product
- Product
- 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 (2:1).
- Manufacturer
- TEI Biosciences, Inc.
- Hazard
- Affected units
- 10,159
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): 607-105-112 (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).
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.
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