Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cypher MIS Screw System-The system includes screws Recalled by Ebi, Llc Due to Inoperative screw head seat splay and/or fracture as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ebi, Llc directly.
Affected Products
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.
Quantity: 2816 approx.units ( 2688 units US and 128 OUS)
Why Was This 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.
Where Was This Sold?
This product was distributed to 9 states: AL, CA, CT, IN, LA, NJ, NC, TX, WI
About Ebi, Llc
Ebi, Llc has 9 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report