FDAFDA · Food and drugs·Recall number Z-2361-2012
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.
Published September 19, 2012 · Recall initiated: January 24, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- Nationwide distribution: USA state of: Arkansas only
- Lot
- Catalog Number 101-05-20; Serial Numbers: 2179820 and 2216759.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.