Device recall
Z-1545-2015: Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable…
FDA device recall · Class II · Incisive Surgical Inc
Key facts
| Recall number (Z-number) | Z-1545-2015 |
|---|---|
| Recall event | 70906 |
| Product | Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester derived from lactic and glycolic acids. It is chemically similar to other surgical glycolide/lactide-based copolymers. Polyglycolic/polylactic acid copolymers degrade in vivo by… |
| Product code | GDW |
| Recalling firm | Incisive Surgical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2015 |
| 510(k) numbers | K024117, K033602, K061784, K090159, K120373 |
| FEI number | 3004028675 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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