Recall Z-2761-2016 ยท GAR Suture, Nonabsorbable, Synthetic, Polyamide
Riverpoint Medical, LLC
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.
| Date | Aug 5, 2016 |
| Status | Terminated |
| Reason | Nylon Surgical Sutures are recalled because the seals may become open during distribution or subsequent packaging. |
| Root 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100006 | HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED Riverpoint Medical, May 10, 2010 |