Device 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
Z-2214-2013
Product summary
- Firm
- Ebi, Llc
- Event
- Event 66098
- Status
- Terminated
- Classification
- Class II
- Quantity
- 427 units
- Official record key
device-enforcement:Z-2214-2013
Official wording
Reason: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
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
Distribution pattern: Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
Derived failure modes
-
Unknown
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.