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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 Recall
Multiaxial Translating MIS Screw
see related information
Date Posted September 17, 2013
Recall Status1 Open
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, New Jersey 07054-1149
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Danielle Wernikowski
973-299-9300 Ext. 2162
Manufacturer Reason
for Recall
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
FDA Determined
Cause 2
DESIGN: 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.
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