The Recall Desk

FDA (Devices) recall action 81127

Zimmer Biomet, Inc. recalled 2 products on 2018-11-07

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2018-11-07
Critical
0
Units
—

Why these products were recalled

Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met.

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2018-11-07

    Zimmer Biomet Recalls SpF PLUS-Mini Spinal Fusion Stimulators for Cleanliness Issues

    Zimmer Biomet is recalling SpF PLUS-Mini implantable spinal fusion stimulators because the company lacked adequate validation to ensure product cleanliness parameters were consistently met.

    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
    Category
    Distribution
    46 states
  • SevereFDA (Devices)··2018-11-07

    Zimmer Biomet Recalls OsteoGen Bone Growth Stimulators for Cleanliness Issues

    Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.

    Product
    EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
    Category
    Distribution
    46 states