Device recall
Z-0612-2018: A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by…
FDA device recall · Class II · Zimmer Surgical Inc
Key facts
| Recall number (Z-number) | Z-0612-2018 |
|---|---|
| Recall event | 78759 |
| Product | A.T.S. 4000TS Tourniquet Systems, Personalized Pressure. Intended to be used by qualified professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities. . |
| Product code | KCY |
| Recalling firm | Zimmer Surgical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 1, 2019 |
| 510(k) numbers | K123553 |
| FEI number | 1526350 |
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