Device recall
Z-0854-2009: Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only…
FDA device recall · Class II · Integra LifeSciences Corp.
Key facts
| Recall number (Z-number) | Z-0854-2009 |
|---|---|
| Recall event | 50112 |
| Product | Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536 |
| Product code | LXH |
| Recalling firm | Integra LifeSciences Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 15, 2009 |
| FEI number | 3003418325 |
At a glance
- None 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