Reported Aug 14, 2019 · Terminated
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only, Part Number…
Geistlich Pharma North America, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Geistlich Pharma North America, Inc. · 202 Carnegie Ctr Ste 103 · Princeton, NJ · 08540-6239
Is this the product you have?
- Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only
- Part Number 20115 - Product UsageAugmentation or reconstructive treatment of the alveolar ridge; Filling of infrabony periodontal defects; Filling of defects after root resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc
- Lot codes and dates
- Lots
81600759817001938170081081701004818002888180086281900056
- Lots
- Amount recalled
- 244,268 total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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