TEI Biosciences, Inc.: Medical Device Recall in 2023 - (Recall #: Z-2078-2023)

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 Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

Product Classification:

Class II

Date Initiated: May 23, 2023

Date Posted: July 12, 2023

Recall Number: Z-2078-2023

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: 30,528 units

Code Information:

Item No. (UDI-DI): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).

Distribution Pattern:

Domestic: Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated