Device recall
Z-0659-2013: The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non…
FDA device recall · Class II · Zimmer, Inc.
Key facts
| Recall number (Z-number) | Z-0659-2013 |
|---|---|
| Recall event | 63559 |
| Product | The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only. The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the knob of the inserter shaft allowing the… |
| Product code | MAX |
| Recalling firm | Zimmer, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 23, 2014 |
| 510(k) numbers | K113561 |
| FEI number | 1000220733 |
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