Recall Z-1691-2017— Zimmer Biomet Spine, Inc

Class II FDA medical device recall by Zimmer Biomet Spine, Inc, initiated 2017-03-16, terminated 2018-07-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); spondylolisthesis; spinal stenosis; fracture/dislocation; atlantoaxial fracture with instability; occipitocervical dislocation; revision of previous cervical spine surgery; and tumors. The occipital bone screws are limited to occipital fixation only. Reason: Zimmer Biomet is recalling the Altius M-INI OCT Posterior Spinal Fixation System because the driver is unable to mate with the screw head tulip..

Recalling firm

Zimmer Biomet Spine, Inc

Classification

Class II

Status

Terminated

Initiated

2017-03-16

Terminated

2018-07-30

Firm location

Broomfield, CO, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.