Z-1811-2014Class II

Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System

Name: Z-1811-2014 Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System
Creator: Ebi, Llc
Published: 2014-05-15
License: https://open.fda.gov/license/

Ebi, LLC / initiated 2014-05-15 / Terminated / root cause: manufacturing process

FDA source

Ebi, Llc began a recall of Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System on 2014-05-15. FDA classified it as Class II and gives the reason as "The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1811-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-06-17
Terminated: 2017-04-21
Recalling firm: Ebi, LLC
Product: Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Product code: HXX Screwdriver
Reason for recall: The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet sent an "Urgent Medical Device Recall Notice"/Fax Back Response Form dated May 15, 2014, via Fed Ex to all affected customers. The notice identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located to remove the product from circulation; follow instructions on the attached Fax Back Response Form prior to return of the product; and return the product using the Fed Ex label included with the notification. Customers were instructed, if if they further distributed the product, they must notify their customers of the recall via the enclosed "Dear O.R. Manger" notice. If the customers had any questions they were asked to please contact Biomet, Monday through Friday (8 am to 5 pm) at 973.299.9300 xt. 2322.
Quantity in commerce: 32 units (30 domestic and 2 international)
Distribution: Worldwide Distribution - USA (nationwide) and the country The Netherlands.
Product codes and lots: Catalog Number 14-501669; Lot Number 006731

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1811-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1811-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-25	2014-06-17

Product code HXX

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)