Exactech, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0168-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 10, 2019

Date Posted: October 30, 2019

Recall Number: Z-0168-2020

Event ID: 83855

Reason for Recall:

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

Status: Terminated

Product Quantity: 158 devices

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.

Voluntary or Mandated:

Voluntary: Firm initiated