Device recall
Z-0287-2019: SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini…
FDA device recall · Class I · Zimmer Biomet, Inc.
Key facts
| Recall number (Z-number) | Z-0287-2019 |
|---|---|
| Recall event | 81127 |
| Product | SpF PLUS-Mini (60 A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels |
| Product code | LOE |
| Recalling firm | Zimmer Biomet, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 25, 2020 |
| PMA numbers | P850035 |
| FEI number | 1000220733 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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