Device product
Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
Z-1514-2026
Product summary
- Event
- Event 98342
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 31 units (OUS only)
- Official record key
device-enforcement:Z-1514-2026
Official wording
Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Code information: Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;
Distribution pattern: Worldwide - US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.
Derived failure modes
-
Unknown
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.