Z-2214-2013Class II

Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical...

Name: Z-2214-2013 Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical...
Creator: Ebi, Llc
Published: 2013-08-13
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2013-08-13 / Terminated / root cause: design

FDA source

Ebi, Llc began a recall of Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660... on 2013-08-13. FDA classified it as Class II and gives the reason as "Several complaints were reported to exhibit screw head splay in 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-2214-2013
Classification: Class II
Status: Terminated
Initiated: 2013-08-13
Posted: 2013-09-17
Terminated: 2015-03-11
Recalling firm: Ebi, LLC
Product: Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Screw System is a non-cervical spinal fixation device. 1)Screw Tower - REF 14-501660 2) Rod Reduce - REF 14-501661 3) Counter Torque - REF 14-501662
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet Spine & Bone Healing Technologies sent "Urgent Medical Device Recall Notice" letters with Fax-Back Response Forms dated 8/13/2013 to distributors and OR managers via Fed Ex. Follow-up e-mails with a copy of the Recall Notice were sent to distributors on 8/13/2013. Customers with questions may contact 973-299-9300 x2162 Monday to Friday from 8:00 am to 5:00 pm EST.
Quantity in commerce: 427 units
Distribution: Nationwide Distribution (US), including the states of IN, MD, MS, NC, OH, PA, SC, and TX.
Product codes and lots: 14-501660 Screw Tower Lots IT0024 IT0025 IT0026 IT0027 IT0028 IT0029 14-501661 Rod Reducer Lots IT0015 IT0022 IT0023 14-501662 Counter Torque Lots IT0020 IT0021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2214-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2214-2013	Class II	Terminated	Voluntary: Firm initiated	2013-09-25	2013-09-17

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)