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U.S. Department of Health and Human Services

Class 2 Device Recall Nylon Surgical Suture

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  Class 2 Device Recall Nylon Surgical Suture see related information
Date Initiated by Firm August 05, 2016
Create Date September 08, 2016
Recall Status1 Terminated 3 on December 22, 2016
Recall Number Z-2761-2016
Recall Event ID 74891
510(K)Number K100006  
Product Classification Suture, nonabsorbable, synthetic, polyamide - Product Code GAR
Product Nylon Surgical Suture for human use and vet use, sold under brand name Riverlon, Securolon, Weblon. Product is sterile. Part numbers:
663BK
663BL
664BL
928BK

Product Usage:
For use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Code Information Lot For human use:  160210-02.  Lots For Vet use:  160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01 
Recalling Firm/
Manufacturer
Riverpoint Medical, LLC
825 NE 25th Ave
Portland OR 97232-2304
For Additional Information Contact Edwin Anderson
866-445-4929
Manufacturer Reason
for Recall
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Riverpoint Medical sent an Urgent Medical Device letter, dated August 5. 2016, and the Customer Response Form to their customers via email. The letter identified the affected product, problem and actions to be taken. Customers are instructed to check inventory, discontinue selling affected sutures and return affected devices to the firm. Distributors are instructed to notify their downstream customers. Consignees should submit the Customer Response Forms. For questions call Riverpoint Medical at 1-866-445-4929.
Quantity in Commerce 2110 boxes distributed in the US and 72 boxes distributed outside US
Distribution US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
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 = GAR and Original Applicant = RIVERPOINT MEDICAL
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