Device recall
Z-1877-2008: PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-1877-2008 |
|---|---|
| Recall event | 48621 |
| Product | PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of trauma to the hindfoot and distal tibia. The nail affords rigid, load sharing fixation that… |
| Product code | HSB |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 16, 2008 |
| 510(k) numbers | K050882 |
| 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