FDA-Device2013-09-25Class II
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
Ebi, Llc
Hazard
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Sold states
Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
Affected count
427 units
Manufactured in
100 Interpace Pkwy, N/A, Parsippany, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2214-2013Don't want to check this manually?
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