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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Product Detail

Product Description REF 101-45-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 4.5mm***Use with 40mm 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.
Recall Number Z-2366-2012
Classification Class II
Code Info Catalog Number: 101-45-20. Serial Numbers:2139099 and 2139100.
Product Distributed Qty 2
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.

Event Detail

Event Id 62140
Product Type Devices
Status Ongoing
Recalling Firm Exactech, Inc.
City Gainesville
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-01-24
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nationwide distribution: USA state of: Arkansas only