This recall is due to a possible thread form issue for the locking holes in that the locking screws may not properly mate with the plate. The improperly mated screw may not be readily recognizable by the user since the screw may not correctly lock. There are no specific patient monitoring instructions recommended beyond the existing follow-up schedule for previously implanted products. The issue was discovered through a complaint investigation. There have been 24 complaints received. Recall Start Date: March 27, 2024
RecallTracker