Device recall
Z-0478-2008: Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained…
FDA device recall · Class II · Blackstone Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0478-2008 |
|---|---|
| Recall event | 45513 |
| Product | Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Systems consists of an assortment of implantable titanium alloy plates and bone screws that are… |
| Product code | KWQ |
| Recalling firm | Blackstone Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 6, 2008 |
| 510(k) numbers | K050892 |
| FEI number | 3001238051 |
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