FDA recall Z-2072-2023

Product

SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x20 cm, 20x25cm, 10x15cm Semi-Oval,

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-2072-2023