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U.S. Department of Health and Human Services

Class 2 Device Recall NOVATION MODULAR DRILL BIT

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  Class 2 Device Recall NOVATION MODULAR DRILL BIT see related information
Date Initiated by Firm January 24, 2012
Date Posted September 11, 2012
Recall Status1 Terminated 3 on September 26, 2012
Recall Number Z-2361-2012
Recall Event ID 62140
Product Classification Bit, drill - Product Code HTW
Product REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***.

To assist the surgeon in the implantation of Novation Hip system components in according to a conventional technique for hemi & total hip arthroplasty. Specifically, these instruments are reusable, surgically invasive, and intended for transient use.
Code Information Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759. 
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Graham L. Cuthbert
352-327-4613
Manufacturer Reason
for Recall		 Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while in a non-sterile condition.
FDA Determined
Cause 2		 Finished device change control
Action The firm, Exactech, Inc., called the lone customer on January 24, 2012 to discuss the product, problem and actions to be taken. The customer was instructed to return all unused devices and associated packaging.
Quantity in Commerce 2
Distribution Nationwide distribution: USA state of: Arkansas only
Total Product Life Cycle TPLC 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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