Device recall
Z-1698-2012: Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys…
FDA device recall · Class II · Genesys Orthopedic Systems, LLC
Key facts
| Recall number (Z-number) | Z-1698-2012 |
|---|---|
| Recall event | 61623 |
| Product | Transforminal Lumbar Interbody Fusion (TLIF) PEEK Inserter used in the Genesys Spine Apache" Interbody Fusion System. The TLIF PEEK inserter is used to introduce the TLIF PEEK implant into the patients spine by threading the implant onto the tip of the inserter shaft. Once the implant is seated… |
| Product code | MAX |
| Recalling firm | Genesys Orthopedic Systems, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 4, 2012 |
| 510(k) numbers | K103034 |
| FEI number | 3008455034 |
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