Device recall
Z-2032-2014: Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED…
FDA device recall · Class II · Zimmer Manufacturing B.V.
Key facts
| Recall number (Z-number) | Z-2032-2014 |
|---|---|
| Recall event | 68547 |
| Product | Zimmer EDI PERIARTICULAR PLATING SYSTEM CANCELLOUS BONE SCREW, FULLY THREADED, HEX HEAD 4MM DIAMETER, 14 MM LENGTH, and EDI 4.0 MM CANCELLOUS SCREW, FULLY THREADED, 20 MM LENGTH. Temporary internal fixation devices, designed to stabilize fractures during the normal healing process. |
| Product code | HWC |
| Recalling firm | Zimmer Manufacturing B.V. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 24, 2015 |
| 510(k) numbers | K934765 |
| FEI number | 1000132037 |
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