Device recall
Z-3034-2011: Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile…
FDA device recall · Class II · Interventional Spine Inc
Key facts
| Recall number (Z-number) | Z-3034-2011 |
|---|---|
| Recall event | 58381 |
| Product | Catalog # 9024-00 or LSW-S-3040 for 4.5mm BONE-LOK PLS Implant A sterile, canulated screw that is supplied as a stand-alone product. The 4.5mm BONE-LOK PLS Implant is also supplied as a component of the Single Use PERPOS PLS System (9045-01 and 9045-02). The labeling and instructions for use for the… |
| Product code | MRW |
| Recalling firm | Interventional Spine Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 11, 2013 |
| 510(k) numbers | K043351 |
| FEI number | 3003523239 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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