The Recall Desk

FDA (Devices) recall action 86164

Globus Medical, Inc. recalled 22 products on 2020-09-02

The FDA (Devices) publishes a recall like this one as 22 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 22 pages.

Products
22
Announced
2020-09-02
Critical
0
Units

Why these products were recalled

Specific lots of ALTERA¿ implants have internal components that may have been manufactured using stainless steel rather than the specified cobalt chromium molybdenum alloy.

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

1–22 of 22

  • SevereFDA (Devices)··2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacer Implants Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacer implants because internal components may have been made of stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 8-12mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 15¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 10-14mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 8-12mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 12-16mm, 15¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 12-16mm, 15¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 12-16mm, 15¿
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 9-13mm, 15¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    FDA Recalls Specific Lots of ALTERA Spacers Due to Material Defect

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been made with stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 9-13mm, 15¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x36, 10-14mm, 15¿
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x26, 9-13mm, 15¿
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2020-09-02

    Globus Medical Recalls Specific Lots of ALTERA Spacers Due to Material Error

    Globus Medical is recalling specific lots of ALTERA Spacers because internal components may have been manufactured using stainless steel instead of the specified cobalt chromium molybdenum alloy.

    Product
    ALTERA Spacer ALTERA Spacer, 10x31, 10-14mm, 8¿
    Category
    Distribution
    0 states