Device 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.
Z-2146-2019
Product summary
- Event
- Event 82636
- Status
- Terminated
- Classification
- Class II
- Quantity
- 244,268 total
- Official record key
device-enforcement:Z-2146-2019
Official wording
Reason: When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.
Code information: Lots: 81600760, 81700194, 81700829, 81800289, 81800863.
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
When unscrewing the green cap from the pen, a visible piece of green plastic was seen on the outer barrel of the pen.