Device recall
Z-1008-2025: Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132…
FDA device recall · Class II · Integrity Implants Inc.
Key facts
| Recall number (Z-number) | Z-1008-2025 |
|---|---|
| Recall event | 96099 |
| Product | Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A Product Description: The Repeater Bone Tamp is a cylindrical shaft used to push bone graft material through a corresponding bone funnel into the FlareHawk interbody fusion device in spinal fusion… |
| Product code | LXH |
| Recalling firm | Integrity Implants Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3012797630 |
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