TEI Biosciences, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2080-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

Product Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 12, 2023

Recall Number: Z-2080-2023

Event ID: 92481

Reason for Recall:

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Status: Ongoing

Product Quantity: 1,689 units

Code Information:

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 Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated