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.
This recall has been terminated (originally issued August 5, 2016).
- Company
- Riverpoint Medical, Llc
- Recall Initiated
- August 5, 2016
- Terminated
- December 22, 2016
- Recall Number
- Z-2761-2016
- Quantity
- 2110 boxes distributed in the US and 72 boxes distributed outside US
- Firm Location
- Portland, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging.
Distribution
US Nationwide distribution in the states of ID, MA, OR, NY and in the country of Australia.
Lot / Code Info
Lot For human use: 160210-02. Lots For Vet use: 160223-03V 160302-06V 160202-01V 160217-02V 160224-03V 160218-03V 160204-01
Root Cause
Nonconforming Material/Component
Action Taken
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.