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
Reported: September 25, 2013 Initiated: August 13, 2013 #Z-2214-2013
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.
Details
- Recalling Firm
- Ebi, Llc
- Units Affected
- 427 units
- Distribution
- Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Ebi, Llc. Units affected: 427 units.
Why was this product recalled? ▼
Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 25, 2013. Severity: Moderate. Recall number: Z-2214-2013.
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