Exactech, Inc. recalls Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder Syst…

Recall date

September 10, 2019

Source

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

Recall number

Z-0168-2020

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.

Why it was recalled

Potential for the wire to fracture at the threads and remain in the glenoid.

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

What was recalled

Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.