Z-0807-2021Class II

VERITAS Collagen Matrix -

Name: Z-0807-2021 VERITAS Collagen Matrix -
Creator: Baxter Healthcare Corporation
Published: 2020-12-11
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2020-12-11 / Terminated / root cause: manufacturing process

FDA source

Baxter Healthcare Corporation began a recall of VERITAS Collagen Matrix - Product Usage: intended for use in reconstruction of the pelvic floor excluding transvaginal pelvic organ prolapse and for use in the... on 2020-12-11. FDA classified it as Class II and gives the reason as "VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0807-2021
Classification: Class II
Status: Terminated
Initiated: 2020-12-11
Posted: 2021-01-08
Terminated: 2023-03-24
Recalling firm: Baxter Healthcare Corporation
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.
Product code: FTM Mesh, Surgical
Reason for recall: VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
Root cause tag: manufacturing process
FDA root cause: Process design
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.
Quantity in commerce: 192 units
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.
Product codes and lots: Product Code: RM1225BIO, RM1225; GTIN: 00085412531274; Lot Number/Expiration Date: SP20A15-1421512/ 10/8/2022, SP20F22-1459746/ 4/1/2023. SP20I03-1474281/ 6/30/2023, SP19K25-1412935/ 7/1/2022, SP19K25-1412937/ 7/1/2022, SP19L09-1415842/ 10/8/2022, SP20A16-1421898/ 10/8/2022, SP20B18-1429818/ 1/2/2023, SP20B20-1430375/ 1/2/2023, SP20C27-1439804/ 2/11/2023, SP20C27-1439818/ 2/11/2023, SP20D01-1440793/ 2/25/2023, SP20D28-1447333/ 2/25/2023, SP20E28-1454035/ 4/1/2023, SP20G08-1462458/ 4/30/2023, SP20G14-1463550/ 4/30/2023, SP20G14-1463605/ 4/30/2023, SP20G21-1465131/ 6/2/2023, SP20G14-1463552/ 6/2/2023, SP20I08-1474874/ 6/30/2023, SP20I08-1474885/ 8/5/2023, SP20I08-1474895/ 8/5/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0807-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0807-2021	Class II	Terminated	Voluntary: Firm initiated	2021-01-20	2021-01-08

Product code FTM

K062915Class IIVeritas Collagen MatrixSynovis Surgical Innovations / cleared 2006-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)