Device recall
Z-2152-2015: Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial…
FDA device recall · Class II · Biomet Spine, LLC
Key facts
| Recall number (Z-number) | Z-2152-2015 |
|---|---|
| Recall event | 70961 |
| Product | Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component. |
| Product code | NKB |
| Recalling firm | Biomet Spine, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 21, 2015 |
| 510(k) numbers | K133746 |
| FEI number | 3010928172 |
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