Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture

  • 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 PolyglycolicLactic Acid Absorbable Surgical Suturesee related information
Date Initiated by FirmDecember 13, 2012
Date PostedNovember 18, 2013
Recall Status1 Terminated 3 on November 21, 2013
Recall NumberZ-0347-2014
Recall Event ID 65584
510(K)NumberK100461 
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
ProductPolyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
Code Information Lot 120716-01
FEI Number 3006981798
Recalling Firm/
Manufacturer		 Riverpoint Medical, LLC
825 NE 25th Ave
Portland OR 97232-2304
For Additional Information ContactDoug Rowley
503-517-8001
Manufacturer Reason
for Recall		Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
FDA Determined
Cause 2		Employee error
ActionRiverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement. For questions regarding this recall call 503-517-8001.
Quantity in Commerce1932 pieces
DistributionUS Distribution in the states of: AZ, FL, and TX.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = NEW
-
-