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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves visible foreign material (plastic debris) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Geistlich Pharma North America, Inc. is recalling Geistlich Bio-Oss Pen units, sterile cancellous granules in an applicator, due to a manufacturing defect. The recall involves 244,268 units distributed nationwide in the United States.
The recall was initiated after a visible piece of green plastic was observed on the outer barrel of the pen when the green cap was unscrewed. The affected lots are 81600760, 81700194, 81700829, 81800289, and 81800863.
Healthcare professionals and patients should stop using the affected Geistlich Bio-Oss Pen units and contact Geistlich Pharma North America, Inc. for further instructions or a replacement.
The recalled product
- 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…
- Manufacturer
- Geistlich Pharma North America, Inc.
- Hazard
- Affected units
- 244,268
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Lots: 81600760
- 81700194
- 81700829
- 81800289
- 81800863.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Geistlich Pharma North America, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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- ModerateGeistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris
FDA (Devices) · 2019-08-14
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