Recall Z-0807-2021— Baxter Healthcare Corporation

Name: FDA recall Z-0807-2021
Creator: U.S. Food and Drug Administration
Published: 2020-12-11

Class II · Terminated

Class II FDA medical device recall by Baxter Healthcare Corporation, initiated 2020-12-11, terminated 2023-03-24. It names one FDA 510(k) clearance: K062915. 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: VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions..

Recalling firm: Baxter Healthcare Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-12-11
Terminated: 2023-03-24
Firm location: Deerfield, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K062915 — VERITAS COLLAGEN MATRIXSynovis Surgical Innovations·cleared 2006-12-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.