Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Multiaxial Translating MIS Screw

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Multiaxial Translating MIS Screw see related information
Date Initiated by Firm August 13, 2013
Date Posted September 17, 2013
Recall Status1 Terminated 3 on March 11, 2015
Recall Number Z-2214-2013
Recall Event ID 66098
Product Classification Orthopedic manual surgical instrument - Product Code LXH
Product Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device.
1)Screw Tower - REF 14-501660
2) Rod Reduce - REF 14-501661
3) Counter Torque - REF 14-501662
Code Information 14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029  14-501661 Rod Reducer Lots IT0015 IT0022 IT0023  14-501662 Counter Torque Lots IT0020 IT0021
Recalling Firm/
Manufacturer		 Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
For Additional Information Contact Ms. Danielle Wernikowski
904-741-4400
Manufacturer Reason
for Recall		 Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
FDA Determined
Cause 2		 Device Design
Action Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST.
Quantity in Commerce 427 units
Distribution Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
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.
-
-