Z-0415-2018 Class II Terminated
FDA device recall Z-0415-2018 was initiated by Exactech, Inc. on August 31, 2017 and is designated Class II. Reason for recall: Potentially mislabeled. The recall status is terminated (terminated August 6, 2019). Affected quantity: 30.
Recall Details
- Product Type
- Devices
- Report Date
- February 7, 2018
- Initiation Date
- August 31, 2017
- Termination Date
- August 6, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 30
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.
Reason for Recall
Potentially mislabeled.
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
Code Information
Catalog #: 314-13-03 Serial Range: 5013020 - 5013049