—#110251

Product

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 product code: HTW — Bit, Drill
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Catalog Number: 101-45-30. Serial Numbers:2139027 and 2139028.

Why it was recalled

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 (FDA determination)

Finished device change control

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

Distribution pattern: Nationwide distribution: USA state of: Arkansas only

Timeline

Recall initiated: 2012-01-24
Posted by FDA: 2012-09-11
Terminated: 2012-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #110251. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.