Exactech, Inc. recalls Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system compone…

Recall date

May 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2644-2017

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, C…

Why it was recalled

The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip