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.
Z-0168-2020
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 83855
- Status
- Terminated
- Classification
- Class II
- Quantity
- 158 devices
- Official record key
device-enforcement:Z-0168-2020
Official wording
Reason: Potential for the wire to fracture at the threads and remain in the glenoid.
Code information: Catalog Number: 321-52-06, All Serial Numbers
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.
Derived failure modes
-
Unknown
Potential for the wire to fracture at the threads and remain in the glenoid.