The Recall Desk
HighFDA (Devices)·Z-2082-2023·Announced 2023-07-12

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.

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 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.
Category
Medical Device — Dermal Repair / Wound Care
Hazard
  • endotoxin
  • contamination

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.

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