Class 2 Device Recall Geistlich BioOss Pen

• Date Initiated by Firm: April 12, 2019
• Date Posted: August 02, 2019
• Recall Status: Terminated on October 21, 2020
• Recall Number: Z-2145-2019
• 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, 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.
• Code Information: Lots: 81600759, 81700193, 81700810, 81701004, 81800288, 81800862, 81900056.
• 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: 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