Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0966-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2016-11-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0966-2017
Date of alert
2016-11-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Amendia, Inc
Product category
device
Product type
Devices
Reported risk: Absent tantalum market pin.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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