FDA recall Z-2077-2023

TEI Biosciences, Inc. · Class II · device

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.

Reason for recall

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

Distribution

Domestic: Nationwide Distribution.

Key facts

Status
Ongoing
Initiation date
2023-05-23
Report date
2023-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Boston, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2077-2023