Device recall
Z-0218-2010: Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface…
FDA device recall · Class II · Zimmer Inc.
Key facts
| Recall number (Z-number) | Z-0218-2010 |
|---|---|
| Recall event | 53399 |
| Product | Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5424-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or… |
| Product code | JWH |
| Recalling firm | Zimmer Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2011 |
| 510(k) numbers | K070214 |
| FEI number | 1000220733 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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