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

FDA device recall Z-1811-2014 · posted 2014-06-17 · Terminated

Recall details

Recalling firm

Ebi, Llc

Reason for recall

The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

HXX

Quantity affected

32 units (30 domestic and 2 international)

Distribution

Worldwide Distribution - USA (nationwide) and the country The Netherlands.

Date initiated

2014-05-15

Date posted

2014-06-17

Date terminated

2017-04-21

Location

Parsippany, NJ