Z-0909-2015Class II

Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various...

Name: Z-0909-2015 Cypher MIS Screw System-The system includes screws, various types and sizes of rods, and set screws. Various...
Creator: Ebi, Llc
Published: 2014-10-08
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2014-10-08 / Terminated / root cause: design

FDA source

Ebi, Llc began a recall of 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... on 2014-10-08. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0909-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Posted: 2015-01-05
Terminated: 2015-12-21
Recalling firm: Ebi, LLC
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, EBI LLC/Biomet, sent an "URGENT PRODUCT INFORMATION" letter dated 10/6/2014 via Fed Ex to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to follow the steps outlined in the letter. If you have any questions, please feel free to contact Director of Regulatory Affairs at 303-501-8548.
Quantity in commerce: 2816 approx.units ( 2688 units US and 128 OUS)
Distribution: Worldwide Distribution: US Distribution to states of: AL, CA, CT, IN, LA, NC, NJ TX & WI; and the country of: The Netherlands.
Product codes and lots: Item Number: 14-571845 5.5 TI 10.5X45MM CANN TRANS 14-571850 5.5 TI 10.5X50MM CANN TRANS 14-571855 5.5 TI 10.5X55MM CANN TRANS 14-571860 5.5 TI 10.5X60MM CANN TRANS 14-571865 5.5 TI 10.5X65MM CANN TRANS 14-571870 5.5 TI 10.5X70MM CANN TRANS 14-571875 5.5 TI 10.5X75MM CANN TRANS 14-571880 5.5 TI 10.5X80MM CANN TRANS 14-571885 5.5 TI 10.5X85MM CANN TRANS 14-571890 5.5 TI 10.5X90MM CANN TRANS 14-571895 5.5 TI 10.5X95MM CANN TRANS 14-571899 5.5 TI 10.5X100MM CANN TRANS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0909-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0909-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05

Product code NKB

K123549Class IIPolaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) / cleared 2013-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)