Z-0168-2020 Class II Terminated
FDA device recall Z-0168-2020 was initiated by Exactech, Inc. on September 10, 2019 and is designated Class II. Reason for recall: Potential for the wire to fracture at the threads and remain in the glenoid. The recall status is terminated (terminated May 1, 2023). Affected quantity: 158 devices.
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