CLASS II Device recall · Reported 14 Aug 2019 · FDA Enforcement Report

Geistlich Bio-Oss Pen, Sterile cancellous granules recalled

Geistlich Pharma North America is recalling Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 25-, For single use, distributed nationwide in the US. The recall was initiated on 12 Apr 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

Quantity recalled244,268 total

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2145-2019
FDA event ID: 82636
Recalling firm: Geistlich Pharma North America, Princeton, NJ
Classification: Class II
Status: Terminated
Recall initiated: 12 Apr 2019
FDA classified: 2 Aug 2019
Reported: 14 Aug 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: E. coli
Device type: Other Medical Devices

Timeline

12 Apr 2019	Recall initiated by company
2 Aug 2019	Classified by FDA	+112 days
14 Aug 2019	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Some strains of E. coli, such as O157:H7, produce a toxin that can cause severe stomach cramps, bloody diarrhea and, in a small number of cases, kidney failure.

Product as listed by the FDA

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 resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 25-, For single use recalled?

Yes. Geistlich Pharma North America recalled Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 25-, For single use on 12 Apr 2019. The recall is Class II and its status is Terminated. Recall number Z-2145-2019.

Why was it recalled?

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

Which lots are affected?

Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Geistlich Pharma North America

All 6

Reported	Class	Recall	Company	Reason	Where
2 Dec 2020Device	CLASS II	Geistlich Bio-Oss Pen recalled by Geistlich Pharma North America	Geistlich Pharma North America	Device Malfunction	Nationwide
2 Dec 2020Device	CLASS II	Geistlich Bio-Oss Pen recalled by Geistlich Pharma North America	Geistlich Pharma North America	Device Malfunction	Nationwide
2 Dec 2020Device	CLASS II	Geistlich Bio-Oss Pen recalled by Geistlich Pharma North America	Geistlich Pharma North America	Device Malfunction	Nationwide
14 Aug 2019Device	CLASS II	Geistlich Bio-Oss Pen, Sterile cancellous granules recalled	Geistlich Pharma North America	E. coli	Nationwide
14 Aug 2019Device	CLASS II	Geistlich Bio-Oss Pen, Sterile cancellous granules recalled	Geistlich Pharma North America	E. coli	Nationwide

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