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Exactech, Inc. recalls REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320
Recalled September 19, 2012 · FDA recall Z-2361-2012 · Exactech
Hazard
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 Class II
Units
2
Sold at
Nationwide distribution: USA state of: Arkansas only
Description
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.
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.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →