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U.S. Department of Health and Human Services

Class 2 Device Recall VERITAS Collagen Matrix

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  Class 2 Device Recall VERITAS Collagen Matrix see related information
Date Initiated by Firm December 11, 2020
Create Date January 08, 2021
Recall Status1 Terminated 3 on March 24, 2023
Recall Number Z-0807-2021
Recall Event ID 86930
510(K)Number K062915  
Product Classification Mesh, surgical - Product Code FTM
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.
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  
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 VERITAS Collagen Matrix 12x25 cm Patches may have undersized width dimensions.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTM and Original Applicant = SYNOVIS SURGICAL INNOVATIONS
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