Device recall
Z-2070-2012: Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-2070-2012 |
|---|---|
| Recall event | 61969 |
| Product | Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***". The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing… |
| Product code | JWH |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 11, 2014 |
| 510(k) numbers | K933610 |
| FEI number | 1038671 |
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