Device recall
Z-2274-2012: Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular…
FDA device recall · Class II · Atlas Spine, Inc.
Key facts
| Recall number (Z-number) | Z-2274-2012 |
|---|---|
| Recall event | 62564 |
| Product | Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date: 03/23/2009***Sleeve… |
| Product code | NKB |
| Recalling firm | Atlas Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 16, 2014 |
| 510(k) numbers | K072426 |
| FEI number | 3003855635 |
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