Z-2364-2012Class II

REF 101-45-20NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mmUse with 20mm...

Name: Z-2364-2012 REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm...
Creator: Exactech, Inc.
Published: 2012-01-24
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2012-01-24 / Terminated / root cause: sterility

FDA source

Exactech, Inc. began a recall of 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... on 2012-01-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-2364-2012
Classification: Class II
Status: Terminated
Initiated: 2012-01-24
Posted: 2012-09-11
Terminated: 2012-09-26
Recalling firm: Exactech, Inc.
Product: 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.
Product code: HTW Bit, Drill
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.
Root cause tag: sterility
FDA root cause: Finished device change control
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.
Quantity in commerce: 2
Distribution: Nationwide distribution: USA state of: Arkansas only
Product codes and lots: Catalog Number: 101-45-20. Serial Numbers:2138948 and 2138950.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2364-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2361-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11
Z-2362-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11
Z-2363-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11
Z-2364-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11
Z-2365-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11
Z-2366-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-19	2012-09-11

Product code HTW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)