Device recall
Z-2071-2012: Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-2071-2012 |
|---|---|
| Recall event | 61969 |
| Product | Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENTED***CoCr Alloy***SIZE 2F/1T***REF 260-04-21***Exactech Gainesville, FL 32653-1630***. The Exactech Optetrak RBK Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for knee pain… |
| Product code | NJL |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2014 |
| FEI number | 1038671 |
At a glance
- None 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