Device recall
Z-0068-2017: BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide…
FDA device recall · Class II · Surgical Specialties Mexico S DE RL DE CV
Key facts
| Recall number (Z-number) | Z-0068-2017 |
|---|---|
| Recall event | 75273 |
| Product | BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection. |
| Product code | OMT |
| Recalling firm | Surgical Specialties Mexico S DE RL DE CV |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 6, 2016 |
| 510(k) numbers | K082438 |
| FEI number | 3010692967 |
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