Recall Z-2214-2013— Ebi, Llc
Class II · Terminated
Class II FDA medical device recall by Ebi, Llc, initiated 2013-08-13, terminated 2015-03-11. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System..
- Recalling firm
- Ebi, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-13
- Terminated
- 2015-03-11
- Firm location
- Parsippany, NJ, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.