The Recall Desk

FDA (Devices) recall action 80421

Integra LifeSciences Corp. recalled 4 products on 2018-08-08

The FDA (Devices) publishes a recall like this one as 4 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 4 pages.

Products
4
Announced
2018-08-08
Critical
0
Units
522

Why these products were recalled

There is a potential for the knob assembly in the swivel adapter to fracture/break during use.

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

1–4 of 4

  • HighFDA (Devices)··2018-08-08

    Integra LifeSciences Recalls Mayfield Spine Table Adaptors Due to Fracture Risk

    Integra LifeSciences is recalling 95 Mayfield Spine Table Adaptors because the knob assembly may fracture during use, posing a risk to patients.

    Product
    MAYFIELD SPINE TABLE ADAPTOR RADIOLUCENT, Part Number A2600R The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Distribution
    45 states
  • HighFDA (Devices)··2018-08-08

    MAYFIELD Infinity XR2 Base Unit Recalled Due to Fracture Risk

    Integra LifeSciences is recalling 17 MAYFIELD Infinity XR2 Base Units because the knob assembly may fracture during use.

    Product
    MAYFIELD Infinity XR2 Base Unit-Extended, Part Number A2079E The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Distribution
    45 states
  • HighFDA (Devices)··2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units

    Integra LifeSciences is recalling 409 Mayfield Infinity XR2 Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 BASE UNIT, Part Number A2079 The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp is…
    Category
    Distribution
    45 states
  • SevereFDA (Devices)··2018-08-08

    Integra LifeSciences Recalls Mayfield Infinity XR2 Base Units Due to Fracture Risk

    Integra LifeSciences is recalling Mayfield Infinity XR2 Low Profile Base Units because the knob assembly in the swivel adapter may fracture or break during use.

    Product
    MAYFIELD INFINITY XR2 LOW PROFILE BASE UNIT, Part Number A2079A The MAYFIELD¿ Infinity XR2 Base Unit is intended to be used to support a patient during diagnostic examination and/or surgical procedures where a rigid support between surgical table and headrest, or skull clamp…
    Category
    Distribution
    45 states