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U.S. Department of Health and Human Services

Class 2 Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm

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  Class 2 Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm see related information
Date Initiated by Firm July 07, 2017
Create Date January 04, 2018
Recall Status1 Terminated 3 on October 15, 2019
Recall Number Z-0316-2018
Recall Event ID 77986
510(K)Number K152972  
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
Product Ceres Self-Drilling Variable Screw 4.0 x 12mm

The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
Code Information Model # 12-31-4012, Lot #133039
Recalling Firm/
Manufacturer		 Amendia, Inc
1755 W Oak Pkwy
Marietta GA 30062-2260
For Additional Information Contact Customer Service
770-575-5224
Manufacturer Reason
for Recall		 Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm, Amendia, sent an "URGENT: MEDICAL DEVICE RECALL" letter to its Customers. The letter described the product, problem and actions to be taken. The customers were Instructed to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia by emailing: jconover@amendia.com or call 770-575-5236 or jwilliamson@amendia or call 770-575-5369, and to complete and return the Response Form. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.
Quantity in Commerce 40 screws
Distribution Distributed to states of: AL, FL, GA, NY, TX, and VA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OVE and Original Applicant = AMENDIA, INC.
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