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U.S. Department of Health and Human Services

Class 2 Device Recall Multiaxial Translating MIS Screw

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 Class 2 Device Recall Multiaxial Translating MIS Screw see related information
Date Posted September 17, 2013
Recall Status1 Terminated 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

14-501661 Rod Reducer Lots

14-501662 Counter Torque Lots
Recalling Firm/
Ebi, Llc
100 Interpace Pkwy
Parsippany NJ 07054-1149
973-299-9300 Ext. 3904
For Additional Information Contact Ms. Danielle Wernikowski
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.