Device recall
Z-1892-2017: The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device…
FDA device recall · Class III · Zimmer Trabecular Metal Technology, Inc.
Key facts
| Recall number (Z-number) | Z-1892-2017 |
|---|---|
| Recall event | 76652 |
| Product | The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and may be used to replace a disc at one or two contiguous levels in L2-S1. The superior and inferior… |
| Product code | MAX |
| Recalling firm | Zimmer Trabecular Metal Technology, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 3, 2017 |
| 510(k) numbers | K113561 |
| FEI number | 3005751028 |
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