Reported Apr 5, 2017 · Terminated
Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT…
Zimmer Biomet Spine, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Biomet Spine, Inc · 310 Interlocken Pkwy · Broomfield, CO · 80021-3479
Is this the product you have?
- 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 forDDD (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
- Lot codes and dates
505951M16562R01505951510710510981514814533566536398543663546565546566549528565465565464567525
- Amount recalled
- 141
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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