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U.S. Department of Health and Human Services

Class 2 Device Recall Geistlich BioOss Pen

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  Class 2 Device Recall Geistlich BioOss Pen see related information
Date Initiated by Firm April 12, 2019
Date Posted August 02, 2019
Recall Status1 Terminated 3 on October 21, 2020
Recall Number Z-2147-2019
Recall Event ID 82636
510(K)Number K120601  
Product Classification Bone grafting material, animal source - Product Code NPM
Product Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126 - 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.
Code Information Lots: 81700464, 81700811, 81800292, 81800866.
Recalling Firm/
Manufacturer		 Geistlich Pharma North America, Inc.
202 Carnegie Ctr Ste 103
Princeton NJ 08540-6239
For Additional Information Contact
202-942-5120
Manufacturer 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 Determined
Cause 2		 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 orders@geistlich-na.com 5) Notify all clinicians within your practice by sharing a copy of the notice.
Quantity in Commerce 244,268 total
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NPM and Original Applicant = GEISTLICH PHARMA AG
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