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U.S. Department of Health and Human Services

Class 2 Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture

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  Class 2 Device Recall PolyglycolicLactic Acid Absorbable Surgical Suture see related information
Date Initiated by Firm December 13, 2012
Date Posted November 18, 2013
Recall Status1 Terminated 3 on November 21, 2013
Recall Number Z-0347-2014
Recall Event ID 65584
510(K)Number K100461  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product Polyglycolic-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
Recalling Firm/
Manufacturer		 Riverpoint Medical, LLC
825 NE 25th Ave
Portland OR 97232-2304
For Additional Information Contact Doug 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
Action Riverpoint 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 Commerce 1932 pieces
Distribution US Distribution in the states of: AZ, FL, and TX.
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 = NEW and Original Applicant = RIVERPOINT MEDICAL
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