The Recall Desk

FDA (Devices) recall action 66935

Materialise USA LLC recalled 2 products on 2014-01-01

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
2014-01-01
Critical
0
Units
2

Why these products were recalled

Patient Specific Guide contained the incorrect case report. The case report contains patient specific surgical plan information.

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.

1–2 of 2

  • HighFDA (Devices)··2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Intermediate Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery.
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2014-01-01

    Materialise Recalls Patient-Specific Orthognathic Surgical Guides Due to Incorrect Case Reports

    Materialise USA LLC is recalling patient-specific orthognathic surgical guides because they contained incorrect case reports with surgical plan information.

    Product
    ProPlan CMF Guide(s) Model(s) REF SD900.008 Description: Single Use Only : Patient-Specific Guide, Orthognathic, Final Single Use Only Rx only. Used as surgical tools to transfer a pre-operative plan to surgery. .
    Category
    Distribution
    0 states