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
    • 505951
    • M16562R01
    • 505951
    • 510710
    • 510981
    • 514814
    • 533566
    • 536398
    • 543663
    • 546565
    • 546566
    • 549528
    • 565465
    • 565464
    • 567525
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 30, 2018 · Data as of Sep 19, 4:45 PM UTC

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