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.
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 source text describes a visible manufacturing defect (plastic debris) without reporting any injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Geistlich Pharma North America, Inc. is recalling Geistlich Bio-Oss Pen applicators, which contain sterile cancellous granules for dental use. 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 product is identified by Part Number 20115 and includes lots 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, and 81900056. A total of 244,268 units were distributed nationwide in the United States. The product is used for augmentation or reconstructive treatment of the alveolar ridge and filling of various dental defects.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected units and contact Geistlich Pharma North America, Inc. for instructions on return or replacement.
The recalled product
- 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…
- 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 (7)
- Lots: 81600759
- 81700193
- 81700810
- 81701004
- 81800288
- 81800862
- 81900056.
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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See all →- HighFDA Recalls Geistlich Bio-Oss Pen Due to Granule Expulsion Risk
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- ModerateGeistlich Bio-Oss Pen Recalled Due to Visible Plastic Debris
FDA (Devices) · 2019-08-14
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