Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Reported: January 14, 2015 Initiated: October 8, 2014 #Z-0909-2015
Product Description
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.
Reason for Recall
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Details
- Recalling Firm
- Ebi, Llc
- Units Affected
- 2816 approx.units ( 2688 units US and 128 OUS)
- Distribution
- Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
- Location
- Parsippany, NJ
Frequently Asked Questions
What product was recalled? ▼
Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various instruments are also available for use by the surgeon to facilitate implantation of the device. Non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion.. Recalled by Ebi, Llc. Units affected: 2816 approx.units ( 2688 units US and 128 OUS).
Why was this product recalled? ▼
Inoperative screw head seat splay and/or fracture as a result of positioning of the rod which is a part of the Cypher MIS Screw System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 14, 2015. Severity: Moderate. Recall number: Z-0909-2015.
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