Device recall
Z-0955-2011: Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0955-2011 |
|---|---|
| Recall event | 57380 |
| Product | Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconstruction. |
| Product code | HRS |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 18, 2011 |
| 510(k) numbers | K070447, K091609 |
| FEI number | 3003418325 |
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