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U.S. Department of Health and Human Services

Class 2 Device Recall SolitaireC Cervical Spacer System

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  Class 2 Device Recall SolitaireC Cervical Spacer System see related information
Date Initiated by Firm November 11, 2014
Date Posted December 24, 2014
Recall Status1 Terminated 3 on April 15, 2015
Recall Number Z-0874-2015
Recall Event ID 69981
510(K)Number K113796  
Product Classification Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
Product Solitaire-C Cervical Spacer System

a) 14-531593 Drill/Awl Sleeve
b) 14-531594 Spring-Loaded Drill/Awl Sleeve

Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Code Information Part number 14-531593 Part number 14-531594  Catalog number Lot Number 14-531593 N23597  14-531594 N23599
Recalling Firm/
Manufacturer		 Ebi, Llc
399 Jefferson Rd
Parsippany NJ 07054-3707
For Additional Information Contact Mr. Stephen Morey
303-501-8568
Manufacturer Reason
for Recall		 A design deficiency was discovered whereby the Drill/Awl Sleeve and Spring-Loaded Drill/Awl Sleeve instruments (the Sleeves) allow the mating Drill and Awl instruments to penetrate 1.0 mm beyond their intended depths during screw hole preparation.
FDA Determined
Cause 2		 Device Design
Action The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 11/11/2014 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and remove from circulation the items consigned/loaned to your account as identified; carefully follow the instructions on the enclosed "Response Form"; complete and return Response Form via fax to 303.501.8444, and if you have further distributed these items to medical facilities, you MUST notify them of the actions. Questions related to this notice should be directed to the Sr. Quality Engineer at 518-859-3487 Monday through Friday, 8 am to 4 pm ET.
Quantity in Commerce 193 units
Distribution US Nationwide Distribution.
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 = EBI, LLC
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