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.
FDA Recall Z-0807-2021 · Posted None
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFTM
Date Initiated2020-12-11
Date Terminated2023-03-24
Product Quantity192 units
Reason for Recall
VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
Firm Action
An Urgent Medical Device Recall communication, FA-2020-057, will be sent to all affected customers via U.S.P.S., first class mail.
Root Cause
Process design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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