Exactech, Inc. recalls Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system componen…

Recall date

July 24, 2019

Source

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

Recall number

Z-2499-2019

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

US distribution to AR, CA, FL, IL, IN, NY, SC, TX.

Why it was recalled

The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.

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

What was recalled

Threaded Offset Cup Impactor - Product Usage: 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.