Device recall
Z-0269-2013: TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent…
FDA device recall · Class II · Alphatec Spine, Inc.
Key facts
| Recall number (Z-number) | Z-0269-2013 |
|---|---|
| Recall event | 63599 |
| Product | TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and pathologies in the… |
| Product code | KWP |
| Recalling firm | Alphatec Spine, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2012 |
| 510(k) numbers | K033090 |
| FEI number | 2027467 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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