Recall Z-0966-2017— Amendia, Inc
Class II · Terminated
Class II FDA medical device recall by Amendia, Inc, initiated 2016-11-22, terminated 2017-02-28. It names one FDA 510(k) clearance: K152972. 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.. Reason: Absent tantalum market pin..
- Recalling firm
- Amendia, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-22
- Terminated
- 2017-02-28
- Firm location
- Marietta, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Absent tantalum market pin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.