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[Recalled] 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 symp
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Amendia, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0966-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 22 November 2016 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Absent tantalum market pin.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Amendia, Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.
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