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U.S. Department of Health and Human Services

Class 2 Device Recall Cypher MIS Screw Inserter

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 Class 2 Device Recall Cypher MIS Screw Insertersee related information
Date Initiated by FirmMay 15, 2014
Date PostedJune 17, 2014
Recall Status1 Terminated 3 on April 21, 2017
Recall NumberZ-1811-2014
Recall Event ID 68526
Product Classification Screwdriver - Product Code HXX
ProductBiomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
Code Information Catalog Number 14-501669; Lot Number 006731
Recalling Firm/
Manufacturer		 Ebi, Llc
399 Jefferson Rd
Parsippany NJ 07054-3707
For Additional Information ContactMs. Karen McCommons
973-299-9300 Ext. 2322
Manufacturer Reason
for Recall		The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionBiomet 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 Commerce32 units (30 domestic and 2 international)
DistributionWorldwide Distribution - USA (nationwide) and the country The Netherlands.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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