Reported Jan 18, 2017 · Terminated

Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated…

Amendia, 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: Amendia, Inc · 1755 W Oak Pkwy · Marietta, GA · 30062-2260

Is this the product you have?

  • Ceres-C Standalone Cervical Interbody The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
Lot codes and dates
    • Part Number 08-170-1010 - Lot Number 134926
    • Part Number 08-170-1011 - Lot Number 134927
    • Part Number 08-170-1006 - Lot Number 134929
    • Part Number 08-170-1008 - Lot Number 134931
Amount recalled
6 devices

Where it was sold

Why it was recalled

Absent tantalum market pin.

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 Feb 28, 2017 · Data as of Sep 19, 4:51 PM UTC

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