The Recall Desk
HighFDA (Devices)·Z-2077-2023·Announced 2023-07-12

PriMatrix Dermal Repair Scaffold recalled due to endotoxin testing issues

TEI Biosciences is recalling 4,159 units of PriMatrix Dermal Repair Scaffold nationwide due to possible out-of-specification endotoxin test results. Quality control issues during testing led to this recall.

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: FDA Class II medical device with potential endotoxin contamination identified through testing; however, no illnesses or injuries reported. The issue was caught at the quality control stage, limiting actual patient exposure.

Plain-English summary

TEI Biosciences, Inc. is recalling 4,159 units of PriMatrix Dermal Repair Scaffold, a medical device for dermal repair. The device is available in multiple sizes: 0.2x26.5 cm (3-pack), 4x4 cm, 6x6 cm, 8x8 cm, 8x12 cm, 10x12 cm, 10x25 cm, and 20x25 cm. The product is distributed nationwide.

The recall is due to possible out-of-specification endotoxin test results from quality control issues with in-process and finished goods endotoxin testing.

Healthcare providers and patients who have received PriMatrix devices should be aware of this recall. No illnesses or injuries have been reported in connection with this issue.

Patients or healthcare providers with questions about affected products should contact TEI Biosciences, Inc. or consult with their healthcare provider.

The recalled product

Product
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Dermal / Wound Care
Hazard
  • endotoxin

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 (8)

  • Item No. (UDI-DI): 607-001-009 (10381780113294)
  • 607-001-112 (10381780113300)
  • 607-001-125 (10381780113317)
  • 607-001-225 (10381780113324)
  • 607-001-440 (10381780113331)
  • 607-001-660 (10381780113348)
  • 607-001-812 (10381780113355)
  • 607-001-880 (10381780113362).

Distribution

Distributed nationwide across the United States.

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