Z-0807-2021 Class II Terminated
FDA device recall Z-0807-2021 was initiated by Baxter Healthcare Corporation on Dec 11, 2020 and is designated Class II. Reason for recall: VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions. The recall status is terminated (terminated Mar 24, 2023). Affected quantity: 192 units.
Recall details
- Product Type
- Devices
- Report Date
- Jan 20, 2021
- Initiation Date
- Dec 11, 2020
- Termination Date
- Mar 24, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 units
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.
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.
Code information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0807-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026