||September 17, 2013
|Recall Event ID
Orthopedic Manual Surgical Instrument - Product Code LXH
||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
||14-501660 Screw Tower Lots
14-501661 Rod Reducer Lots
14-501662 Counter Torque Lots
100 Interpace Pkwy
Parsippany, New Jersey 07054-1149
|For Additional Information Contact
||Ms. Danielle Wernikowski
973-299-9300 Ext. 2162
|Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
|DESIGN: Device Design
||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
||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.