FDA recall Z-2079-2023

Product

PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8x8 cm (2:1).

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-2079-2023