Device recall
Z-0119-2011: NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF…
FDA device recall · Class II · Zimmer Inc.
Key facts
| Recall number (Z-number) | Z-0119-2011 |
|---|---|
| Recall event | 56701 |
| Product | NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium-Molybdenum alloy femoral component and is indicated for cemented use only. |
| Product code | JWH |
| Recalling firm | Zimmer Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 23, 2010 |
| 510(k) numbers | K933785 |
| FEI number | 1000220733 |
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