Z-2214-2013 Class II Terminated
FDA device recall Z-2214-2013 was initiated by Ebi, Llc on August 13, 2013 and is designated Class II. Reason for recall: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. The recall status is terminated (terminated March 11, 2015). Affected quantity: 427 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2013
- Initiation Date
- August 13, 2013
- Termination Date
- March 11, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 427 units
Product Description
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
Reason for Recall
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Distribution Pattern
Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
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