Date Initiated by Firm | January 24, 2012 |
Date Posted | September 11, 2012 |
Recall Status1 |
Terminated 3 on September 26, 2012 |
Recall Number | Z-2364-2012 |
Recall Event ID |
62140 |
Product Classification |
Bit, drill - Product Code HTW
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Product | REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***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: 101-45-20. Serial Numbers:2138948 and 2138950. |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
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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 |
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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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