Device recall
Z-0927-06: Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis…
FDA device recall · Class II · Exactech, Inc.
Key facts
| Recall number (Z-number) | Z-0927-06 |
|---|---|
| Recall event | 34294 |
| Product | Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. '' |
| Product code | JWH |
| Recalling firm | Exactech, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 29, 2012 |
| 510(k) numbers | K932776 |
| 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