Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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.

FDA Recall Z-0966-2017 · Posted 2017-01-09

Recalling FirmAmendia, Inc
Recall StatusTerminated
Product CodeOVE
Date Initiated2016-11-22
Date Terminated2017-02-28
Product Quantity6 devices

Reason for Recall

Absent tantalum market pin.

Firm Action

The firm, Amendia, contacted the consignee and issued a Return Material Authorization for the affected product on 8/18/2016. Please contact Regulatory and Quality Consultant for Amendia at 404-610-7215 or by email to [email protected] with any questions or concerns regarding this recall notification.

Root Cause

Process control

Distribution Pattern

US Distribution to GA only.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152972Amendia Stand-Alone Cervical SystemAmendia, Inc. · 2016-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑