Product Wiki · Recalls · U.S. FDA — Device Enforcement

REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER… — recall Z-2363-2012

U.S. FDA — Device Enforcement · United States · 2012-01-24 · Class II

As described by U.S. FDA — Device Enforcement: 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 hi

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2363-2012
Date of alert
2012-01-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Exactech, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide distribution: USA state of: Arkansas only
Reported risk: 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.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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