Device recall
Z-0458-2009: Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx…
FDA device recall · Class I · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0458-2009 |
|---|---|
| Recall event | 50065 |
| Product | Gravity Compensating Accessory; High Pressure Range, Sterile, Single Use, Rx only. CSF shunt accessory. Manufacturer: Integra Neuro Sciences Implants, SA, Cedex, France; distributed by: Integra NeuroSciences, Plainsboro, NJ 08536 The GCA is an implantable device designed to be used in conjunction… |
| Product code | JXG |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 6, 2009 |
| 510(k) numbers | K932429 |
| 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