Exactech, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0415-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.

Product Classification:

Class II

Date Initiated: August 31, 2017

Date Posted: February 7, 2018

Recall Number: Z-0415-2018

Event ID: 78903

Reason for Recall:

Potentially mislabeled.

Status: Terminated

Product Quantity: 30

Code Information:

Catalog #: 314-13-03 Serial Range: 5013020 - 5013049

Distribution Pattern:

Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland

Voluntary or Mandated:

Voluntary: Firm initiated