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 134926Part Number 08-170-1011 - Lot Number 134927Part Number 08-170-1006 - Lot Number 134929Part 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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