FDA recall Z-0168-2020

Exactech, Inc. · Class II · device

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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-09-10
Report date
2019-10-30
Termination date
2023-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0168-2020