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U.S. Department of Health and Human Services

Class 2 Device Recall Cypher MIS Screw System

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  Class 2 Device Recall Cypher MIS Screw System see related information
Date Initiated by Firm October 08, 2014
Date Posted January 05, 2015
Recall Status1 Terminated 3 on December 21, 2015
Recall Number Z-0909-2015
Recall Event ID 69785
510(K)Number K123549  
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
Product Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device.

Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Code Information Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS 
Recalling Firm/
Ebi, Llc
399 Jefferson Rd
Parsippany NJ 07054-3707
For Additional Information Contact Mr. Mike Medina
Manufacturer Reason
for Recall
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
FDA Determined
Cause 2
Device Design
Action The firm, EBI LLC/Biomet, sent an "URGENT PRODUCT INFORMATION" letter dated 10/6/2014 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter. If you have any questions, please feel free to contact Director of Regulatory Affairs at 303-501-8548.
Quantity in Commerce 2816 approx.units ( 2688 units US and 128 OUS)
Distribution Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
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 = NKB and Original Applicant = BIOMET SPINE (AKA EBI, LLC)