TEI Biosciences, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2082-2023)

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 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).

Product Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 12, 2023

Recall Number: Z-2082-2023

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: 10,159 units

Code Information:

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 Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated