Device recall
Z-0411-2014: Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile…
FDA device recall · Class II · Ebi, Llc
Key facts
| Recall number (Z-number) | Z-0411-2014 |
|---|---|
| Recall event | 66654 |
| Product | Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a… |
| Product code | HXX |
| Recalling firm | Ebi, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 15, 2015 |
| FEI number | 2242816 |
At a glance
- None 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