Recall Z-0909-2015— Ebi, Llc

Name: FDA recall Z-0909-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-08

Class II · Terminated

Class II FDA medical device recall by Ebi, Llc, initiated 2014-10-08, terminated 2015-12-21. It names one FDA 510(k) clearance: K123549. 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 stabilization as an adjunct to fusion.. Reason: 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..

Recalling firm: Ebi, Llc
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Terminated: 2015-12-21
Firm location: Parsippany, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123549 — POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEMBiomet Spine (Aka Ebi, LLC)·cleared 2013-02-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.