Z-1518-2026 Class II Ongoing
FDA device recall Z-1518-2026 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on January 12, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 8 units (OUS only).
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
- 8 units (OUS only)
Product Description
Endo-Model Replacement Plateau; Item Number: 15-8521/09;
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: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045;