Device product
Tapered SwissPlus Implant System, Model No. SPB10
Z-1823-2017
Product summary
- Event
- Event 76746
- Status
- Terminated
- Classification
- Class II
- Quantity
- 188 units
- Official record key
device-enforcement:Z-1823-2017
Official wording
Reason: It was manufactured with the minor diameter of the internal thread that is below specification.
Code information: Lot #63498673; UDI: (01) 008890240177 (10) 63498673 (17) 200731
Distribution pattern: Worldwide: ZA, FR, IT, IR
Derived failure modes
-
Unknown
It was manufactured with the minor diameter of the internal thread that is below specification.