Device recall
Z-0347-2014: Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated…
FDA device recall · Class II · Riverpoint Medical, LLC
Key facts
| Recall number (Z-number) | Z-0347-2014 |
|---|---|
| Recall event | 65584 |
| Product | 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… |
| Product code | NEW |
| Recalling firm | Riverpoint Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 21, 2013 |
| 510(k) numbers | K100461 |
| FEI number | 3006981798 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database