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U.S. Department of Health and Human Services

Class 2 Device Recall CeresC Standalone Cervical Interbody, absent the tantalum market pin

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 Class 2 Device Recall CeresC Standalone Cervical Interbody, absent the tantalum market pinsee related information
Date Initiated by FirmNovember 22, 2016
Date PostedJanuary 09, 2017
Recall Status1 Terminated 3 on February 28, 2017
Recall NumberZ-0966-2017
Recall Event ID 75857
510(K)NumberK152972 
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
ProductCeres-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.
Code Information Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
FEI Number 3007970248
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information ContactBryan Brosseau
404-610-7215
Manufacturer Reason
for Recall		Absent tantalum market pin.
FDA Determined
Cause 2		Process control
ActionThe 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 bbrosseau@securebme.com with any questions or concerns regarding this recall notification.
Quantity in Commerce6 devices
DistributionUS Distribution to GA only.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OVE
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