Ebi Recalls Cypher MIS Screw System Due to Inoperative Screw Heads
Ebi, LLC is recalling the Cypher MIS Screw System because screw heads may splay or fracture, rendering the device inoperative.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (spinal fixation device) where injury has not yet been reported, meeting the criteria for a High severity score.
Plain-English summary
Ebi, LLC is recalling the Cypher MIS Screw System, a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion. The recall involves approximately 2,816 units, including 2,688 units distributed in the United States and 128 units distributed outside the US.
The recall is being conducted because the screw head seat may splay and/or fracture as a result of the positioning of the rod, which is a part of the system. This defect can render the screw head inoperative. The affected product was distributed worldwide, including in the US states of Alabama, California, Connecticut, Indiana, Louisiana, North Carolina, New Jersey, Texas, and Wisconsin, as well as in the Netherlands.
Healthcare providers and patients should contact Ebi, LLC for further information regarding the recall and potential corrective actions.
The recalled product
- Product
- 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…
- Manufacturer
- Ebi, Llc
Distribution
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