FDA recall Z-1338-2019

Product

Integra Flowable Wound Matrix Catalog No: FWD301 Product Usage: Integra Flowable Wound Matrix is indicated for the treatment of tunneling and/or undermined wounds including: surgical wounds (donor sites/grafts, post-Moh s surgery, post-laser surgery, podiatric, wound dehiscence) and diabetic ulcers of both partial and full-thickness varieties. The device is intended for one-time use.

Reason for recall

Stability did not meet acceptance criteria for visual appearance during mixing and force vs. displacement at 6 months

Distribution

Worldwide Distribution - US Nationwide Foreign; Peru, Ecuador, Columbia, Brazil

Key facts

Status

Terminated

Initiation date

2019-03-31

Report date

2019-05-22

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1338-2019