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Exactech, Inc. recalls Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder Syste
Recalled October 30, 2019 · FDA recall Z-0168-2020 · Exactech
Hazard
Potential for the wire to fracture at the threads and remain in the glenoid. · FDA Class II
Units
158 devices
Sold at
US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
Description
Potential for the wire to fracture at the threads and remain in the glenoid.
Product
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.
Manufacturer(s)
Exactech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →