Class 2 Device Recall Nylon Surgical Suture

• Date Initiated by Firm: August 05, 2016
• Create Date: September 08, 2016
• Recall Status: Terminated 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
• FEI Number: 3006981798
• 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: 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