Device recall
Z-1396-2015: Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to…
FDA device recall · Class II · Bacterin International, Inc.
Key facts
| Recall number (Z-number) | Z-1396-2015 |
|---|---|
| Recall event | 70744 |
| Product | Instrument Kit for use with OsteoSponge SC grafts. The Instrument Kit is used to insert OsteoSponge SC grafts to fill bone defects in the subchondral region of articulating joints. The Instrument Kit is used to establish and maintain a port of entry for arthroscopic instruments or for an open… |
| Product code | LXH |
| Recalling firm | Bacterin International, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 1, 2015 |
| FEI number | 3005031160 |
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