Z-0168-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 30, 2019
- Initiation Date
- September 10, 2019
- Termination Date
- May 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 158 devices
Product Description
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 Pattern
US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
Code Information
Catalog Number: 321-52-06, All Serial Numbers