Exactech, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2361-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 24, 2012

Date Posted: September 19, 2012

Recall Number: Z-2361-2012

Event ID: 62140

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.

Status: Terminated

Product Quantity: 2

Code Information:

Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759.

Distribution Pattern:

Nationwide distribution: USA state of: Arkansas only

Voluntary or Mandated:

Voluntary: Firm initiated