FDA recall Z-2084-2023

TEI Biosciences, Inc. · Class II · device

Product

Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 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-2084-2023