Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0909-2015 — 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 adj

U.S. FDA — Device Enforcement · United States · 2014-10-08 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0909-2015
Date of alert: 2014-10-08
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ebi, Llc
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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