Device recall
Z-0572-2011: BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for…
FDA device recall · Class II · Zimmer Inc.
Key facts
| Recall number (Z-number) | Z-0572-2011 |
|---|---|
| Recall event | 56731 |
| Product | BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION INTRAMEDULLARY REAMER used for implantation of the Zimmer Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Shoulder Systems: Catalog Number 00-4301-006/018-00. The intramedullary reamer manual surgical instrument is used in the surgical… |
| Product code | KWT |
| Recalling firm | Zimmer Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 14, 2012 |
| FEI number | 1000220733 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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