The FDA has initiated a Class II recall for Waldemar Link's Endo-Model Replacement Plateau, item number 15-0027/12. The recall is due to a defect where the bushing could detach from the screw shaft because of a longitudinal fracture, potentially affecting the implant's integrity. This recall is ongoing and has worldwide distribution, including nationwide distribution in the US.

Medical device manufacturers and distributors must be aware of this recall and ensure compliance with any associated notification and remediation requirements. While specific compliance deadlines are not detailed in this notice, the nature of a Class II recall necessitates prompt action to address the affected product and prevent patient harm. Failure to comply with recall procedures can result in further FDA enforcement actions.