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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759. Class II 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. 2 Z-2361-2012
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. Catalog Number: 101-45-20. Serial Numbers:2139099 and 2139100. Class II 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. 2 Z-2366-2012
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm 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. Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028. Class II 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. 2 Z-2365-2012
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. Catalog Number: 101-45-20. Serial Numbers:2138948 and 2138950. Class II 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. 2 Z-2364-2012
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***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. Catalog Number: 101-05-40. Serial Numbers:2193123 and 2193124. Class II 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. 2 Z-2363-2012
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm 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. Catalog Number: 101-05-30. Serial Numbers:2218601 and 2218603. Class II 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. 2 Z-2362-2012
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