Device recall
Z-1547-2015: 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine…
FDA device recall · Class II · Alphatec Spine, Inc.
Key facts
| Recall number (Z-number) | Z-1547-2015 |
|---|---|
| Recall event | 70958 |
| Product | 4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm Alphatec Spine Solutions for the Aging Spine Trestle Luxe Anterior Cervical Plating System REF 71240-14 LOT XXXXXX Alphatec Spine, Inc. EN: 4.0MM Variable Angle, Self--Drilling Hexalobe Screw, 14MM (TI-6AL-4V ELI) NON STERILE Single Use Only |
| Product code | KWQ |
| Recalling firm | Alphatec Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2015 |
| 510(k) numbers | K102820 |
| FEI number | 2027467 |
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