The Recall Desk

FDA (Devices) recall action 85611

Medtronic Sofamor Danek USA Inc recalled 3 products on 2020-06-24

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-06-24
Critical
0
Units
83

Why these products were recalled

Product may not maintain its setting characteristics for the labeled shelf-life duration. Use may lead to longer time for product to set at the time of implantation which may increase the required surgical and anesthesia time for the patient. If the device seeps or creeps from its intended position prior to setting and creates incomplete void or gap filling, possible longer-term health consequences could include incomplete bone formation or lack of bone formation, delayed union, or nonunion.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • HighFDA (Devices)··2020-06-24

    Medtronic Bone Void Filler Recalled for Potential Setting Defects

    Medtronic is recalling 36 units of Bone Void Filler, Small, because the product may not maintain its setting characteristics for the labeled shelf-life, potentially increasing surgical time.

    Product
    Medtronic Bone Void Filler, Small - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2020-06-24

    Medtronic Bone Void Filler Recalled for Potential Setting Defects

    Medtronic is recalling 6 units of Bone Void Filler, Large, because the product may not maintain its setting characteristics for the labeled shelf-life.

    Product
    Medtronic Bone Void Filler, Large - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Distribution
    13 states
  • HighFDA (Devices)··2020-06-24

    Medtronic Bone Void Filler Kit Recalled for Setting Defects

    Medtronic is recalling 41 units of Bone Void Filler Kits because the product may not set properly, potentially increasing surgical time and causing incomplete bone formation.

    Product
    Extremities, Large Kit Assy, US, 15/3 - Product Usage: is an injectable, moldable and biocompatible calcium phosphate bone void filler. The single-use Medtronic Bone Void Filler Kit contains the necessary components for mixing of the bone void filler.
    Category
    Distribution
    13 states