Device recall
Z-0359-2014: BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx…
FDA device recall · Class II · Ebi, Llc
Key facts
| Recall number (Z-number) | Z-0359-2014 |
|---|---|
| Recall event | 66300 |
| Product | BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system |
| Product code | HWC |
| Recalling firm | Ebi, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 31, 2016 |
| 510(k) numbers | K123549 |
| FEI number | 2242816 |
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