Recall Z-2146-2019— Geistlich Pharma North America, Inc.
Class II · Terminated
Class II FDA medical device recall by Geistlich Pharma North America, Inc., initiated 2019-04-12, terminated 2020-10-21. It names one FDA 510(k) clearance: K120601. Product: Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - 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.. Reason: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen..
- Recalling firm
- Geistlich Pharma North America, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-04-12
- Terminated
- 2020-10-21
- Firm location
- Princeton, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 0.25-1.mm 0.5g, For single use only, Part Number 20116 - 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.