Device recall
Z-0046-2012: Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional…
FDA device recall · Class II · Interventional Spine Inc
Key facts
| Recall number (Z-number) | Z-0046-2012 |
|---|---|
| Recall event | 58461 |
| Product | Reusable BONE-LOK PLS System; Catalog #'s: 9039-01 and 9039-02. Interventional Spine, Inc. A sterile kit used to stabilize the spine as an aid to fusion through immobilization of the facet joints. Sold in Europe. |
| Product code | HXX |
| Recalling firm | Interventional Spine Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 5, 2013 |
| FEI number | 3003523239 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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