FDAOctober 8, 2014device
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 adju...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
ebi
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 10677182024-03-22
- FDA20" Lead Wires, Replacement Part Number: 1067724-22024-03-22
- FDA48" Lead Wires, Replacement Part Number: 1067724-42024-03-22
- FDABiomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones, Part Number: 10677162024-03-22
- FDA10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.2017-04-20
- FDA10-1398M - SpF-PLUS Implantable Stimulator. Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.2017-04-20
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