Geistlich Bio-Oss Pen, Sterile cancellous granules in an applicator, 1-2mm 0.5g, For single use only, Part Number 20126
FDA device recall Z-2147-2019 · posted 2019-08-02 · Terminated
Recall details
- Recalling firm
- Geistlich Pharma North America, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NPM
- Quantity affected
- 244,268 total
- Distribution
- US Nationwide distribution.
- Date initiated
- 2019-04-12
- Date posted
- 2019-08-02
- Date terminated
- 2020-10-21
- Location
- Princeton, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GEISTLICH 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-O (K120601) | Geistlich Pharma AG | 2012-05-24 |