PriMatrix Ag Dermal Repair Scaffold Recalled for Endotoxin Testing Issues
TEI Biosciences is recalling 1,689 units of PriMatrix Ag dermal repair scaffolds distributed nationwide due to potential endotoxin testing deficiencies. Testing procedures may not have been conducted reliably.
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 recall with potential endotoxin testing deficiencies in a medical device used for wound care. No illnesses or injuries have been reported, and the hazard is based on compromised test procedures rather than confirmed contamination.
Plain-English summary
TEI Biosciences, Inc., is recalling PriMatrix Ag Dermal Repair Scaffolds due to potential issues with endotoxin testing procedures. The products are available in seven sizes: 4x4 cm, 6x6 cm, 8x8 cm, 8x12 cm, 10x12 cm, 10x25 cm, and 20x25 cm.
The recall involves compromised in-process and finished-goods endotoxin testing. Possible out-of-specification test results indicate that testing procedures may not have been conducted reliably, making it uncertain whether endotoxin levels in affected products meet safety specifications.
Approximately 1,689 units have been distributed nationwide to domestic healthcare facilities. Patients, healthcare providers, and facilities with these products should contact the manufacturer or their supplier for guidance on next steps.
The recalled product
- Product
- PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
- Manufacturer
- TEI Biosciences, Inc.
- Category
- Medical Device — Dermal Repair
- Hazard
- Affected units
- 1,689
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): 607-101-112 (10381780113492)
- 607-101-125 (10381780113508)
- 607-101-225 (10381780113515)
- 607-101-440 (10381780113522)
- 607-101-660 (10381780113539)
- 607-101-812 (10381780113546)
- 607-101-880 (10381780113553).
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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