Z-1517-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 18, 2026
- Initiation Date
- January 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 units (all OUS)
Product Description
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Reason for Recall
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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.
Code Information
Item Number: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209;