Z-2145-2019Class II

Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only...

Name: Z-2145-2019 Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.25g, For single use only...
Creator: Geistlich Pharma North America, Inc.
Published: 2019-04-12
License: https://open.fda.gov/license/

Geistlich Pharma North America, Inc / initiated 2019-04-12 / Terminated

FDA source

Geistlich Pharma North America, Inc. began a recall of 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... on 2019-04-12. FDA classified it as Class II and gives the reason as "When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2145-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-12
Posted: 2019-08-02
Terminated: 2020-10-21
Recalling firm: Geistlich Pharma North America, Inc
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 resection, apicoectomy and cystectomy; Filling of extraction sockets to enhance preservation of the alveolar ridge; Elevation of the maxillary sinus floor, etc.
Product code: NPM Bone Grafting Material, Animal Source
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.
FDA root cause: Under Investigation by firm
Action: On April 12, 2019, Geistlich Pharma AG issued URGENT MEDICAL DEVICE CORRECTION NOTICES and Acknowledgement and Receipt Forms to customers via courier service. Customers were advised to take the following actions: 1) When using the device, please assure that the green cap is removed without force, and when removing the filter cap, the cap is turned to the left to loosen as overtightening could damage the cap. 2) Should you observe a similar plastic fragment, DO NOT use the product. Please retain the product and notify the firm by calling 855-799-5500 to arrange a return and replacement. 3) Customers requesting return of product call 855-799-5500 4) Complete and return the Acknowledgement form via email to [email protected] 5) Notify all clinicians within your practice by sharing a copy of the notice.
Quantity in commerce: 244,268 total
Distribution: US Nationwide distribution.
Product codes and lots: Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2145-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2145-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2146-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02
Z-2147-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-02

Product code NPM

K120601Class IIGeistlich Bio-Oss Pen (0.25 G, 0.25-1.0Mm Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0Mm Granules), Geistlich Bio-OGeistlich Pharma AG / cleared 2012-05-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)