Recall Z-0347-2014 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Riverpoint Medical, LLC
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
| Date | Nov 18, 2013 (initiated Dec 13, 2012) |
| Status | Terminated |
| Reason | Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture. |
| Root cause | 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 pro |
| Quantity | 1932 pieces |
| Distribution | US Distribution in the states of: AZ, FL, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100461 | PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT Riverpoint Medical, Jul 8, 2010 |