Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.