Z-1168-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- January 19, 2018
- Termination Date
- July 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,117 units total
Product Description
SwishPlus Implant Intended for use in support for fixed bridgework.
Reason for Recall
The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).
Distribution Pattern
Worldwide Distribution -- US, Europe, Canada, Australia, and Japan.
Code Information
Part No. (Lot No.): 924108 (97347), 924112 (64927, 93563, 98662), 924116 (70543), 924806 (99749), 924810W (93934), 924812W (94204), and 924814 (103199).