The FDA has initiated a Class II device recall (Z-1523-2026) for the Waldemar Link Endo-Model Replacement Plateau, item number 15-0027/16. The recall is due to a manufacturing defect where the bushing could detach from the screw shaft due to a longitudinal fracture, posing a risk of implant failure. The product has been distributed worldwide, including within the United States in New Jersey.

Medical device manufacturers and distributors must review their inventory and distribution records for this product. Healthcare providers should be aware of this recall and take appropriate action regarding affected implants. While the recall is ongoing, specific compliance actions or deadlines are not detailed in this notice, but prompt attention to potential patient safety issues is paramount.