FDA recall Z-0807-2021

Product

VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the repair of rectal prolapse excluding rectocele.

Reason for recall

VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.

Distribution

Worldwide distribution - US Nationwide distribution including in the states of FL, IL, MA, MS, OH, OR, TX, VA, WA, WV and the countries of Australia, Poland, and United Kingdom.

Key facts

Status

Terminated

Initiation date

2020-12-11

Report date

2021-01-20

Termination date

2023-03-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2021