• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Veritas Collagen Matrix

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Veritas Collagen Matrix see related information
Date Initiated by Firm December 11, 2002
Create Date June 25, 2015
Recall Status1 Terminated 3 on May 28, 2003
Recall Number Z-0352-03
Recall Event ID 25226
510(K)Number K002233  
Product Classification unknown device name - Product Code 79F
Product Surgical Mesh
Code Information lot number 547628
Recalling Firm/
Manufacturer
Synovis Surgical Inovation Div. of
2575 University Ave.
St. Paul MN 55114-1024
Manufacturer Reason
for Recall
A gap in the exterior seal may lead to sterility concerns with the interior pouch.
FDA Determined
Cause 2
Other
Action The sites and/or distributors that received suspect devices were contacted by telephone on 12/11/02 and given instructions on how to return/replace the devices. In addition, a letter dated 12/11/02 was sent to each consignee.
Quantity in Commerce 28 devices
Distribution Product shipped nationwide, no foreign consignees

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 = 79F and Original Applicant = BIO-VASCULAR, INC.
-
-