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Terminated

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.

FDA Recall Z-2365-2012 · Posted 2012-09-11

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeHTW
Date Initiated2012-01-24
Date Terminated2012-09-26
Product Quantity2

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.

Firm 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.

Root Cause

Finished device change control

Distribution Pattern

Nationwide distribution: USA state of: Arkansas only

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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