FDA Device recall Z-0287-2019
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion…
- FDA Device
- Class I
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class I recall of SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion… by Zimmer Biomet, citing lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0287-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-02-19 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | US |
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
Reason
Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.
Identifiers
| code_info | Item # 10-1398W - SpF Plus - Mini 60/W; Serial Numbers: 409180, 409203, 409209, 409462, 409468, 409474, 409687, 4097…Item # 10-1398W - SpF Plus - Mini 60/W; Serial Numbers: 409180, 409203, 409209, 409462, 409468, 409474, 409687, 409755, 409760, 409175, 409181, 409204, 409437, 409463, 409469, 409475, 409688, 409756, 409754, 409176, 409182, 409205, 409438, 409464, 409470, 409476, 409751, 409757, 409686, 409177, 409200, 409206, 409439, 409465, 409471, 409684, 409752, 409758, 409473, 409178, 409201, 409207, 409440, 409466, 409472, 409685, 409753, 409759, 409467, 409179, 409202, 409208, and 409441 Item # 10-1398M - SpFPlus - Mini 60/M; Serial Numbers: 408491, 408743, 408995, 409272, 409544, 409809, 410069, 408490, 408463, 408239, 408492, 408744, 408996, 409273, 409545, 409810, 410070, 408467, 408464, 408240, 408493, 408745, 408997, 409274, 409546, 409811, 410071, 408468, 408465, 408241 408494 408746 408998 409275 409547 409812 410072 408469 408466 408242 408495 408747 408999 409276 409548 409813 410073 408470 408716 408243 408496 408748 409001 409277 409549 409 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0287-2019%22
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