The Recall Desk

FDA (Devices) recall action 82636

Geistlich Pharma North America, Inc. recalled 3 products on 2019-08-14

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
2019-08-14
Critical
0
Units
732,804

Why these products were recalled

When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.

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.

1–3 of 3

  • ModerateFDA (Devices)··2019-08-14

    Geistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris

    Geistlich Pharma is recalling Bio-Oss Pen units because visible green plastic debris was found on the outer barrel when unscrewing the cap.

    Product
    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-08-14

    Geistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris

    Geistlich Pharma North America is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.

    Product
    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root…
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2019-08-14

    Geistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris

    Geistlich Pharma is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.

    Product
    Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number 20115 - Product Usage: Augmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root…
    Category
    Distribution
    0 states