Device recall
Z-2173-2010: Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number…
FDA device recall · Class II · Sgarlato Med, LLC
Key facts
| Recall number (Z-number) | Z-2173-2010 |
|---|---|
| Recall event | 55775 |
| Product | Sgarlato Labs GAIT (Great Toe Implant Technique) Implant-- Large, Product Number 30-100-03 Large, Manufactured by Sgarlato Med LLC, San Jose, CA |
| Product code | KWH |
| Recalling firm | Sgarlato Med, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 19, 2011 |
| 510(k) numbers | K905795 |
| FEI number | 2939320 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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