FDA-Device2019-10-30Class II
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.
Exactech, Inc.
Hazard
Potential for the wire to fracture at the threads and remain in the glenoid.
Sold states
US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
Affected count
158 devices
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0168-2020Don't want to check this manually?
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