Zimmer Biomet Spine, Inc recalls Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Sys

Recalled April 5, 2017 · FDA recall Z-1691-2017 · Zimmer Biomet Spine

Hazard

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. · FDA Class II

Units

141

Sold at

Worldwide Distribution - US (nationwide) and Internationally to the Netherlands

Description

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.

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

Manufacturer(s)

Zimmer Biomet Spine, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →