Device recall
Z-2234-2012: OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-2234-2012 |
|---|---|
| Recall event | 62134 |
| Product | OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray color. Use with LOGIC Tibial Components. REF 02--012-42-2508. The Optetrak Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery… |
| Product code | JWH |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2013 |
| 510(k) numbers | K071738 |
| 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