Device product
Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, Rx only, Sterile Dental Implant component.
Z-0007-2018
Product summary
- Event
- Event 77788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 units
- Official record key
device-enforcement:Z-0007-2018
Official wording
Reason: The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.
Code information: Product Code 9048-13H, Lot No. 81080
Distribution pattern: Distribution US nationwide including CA, FL, NJ, NY, PA, TX, & UT.
Derived failure modes
-
Unknown
The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.