FDA recall Z-0415-2018

Exactech, Inc. · Class II · device

Product

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

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

Key facts

Status
Terminated
Initiation date
2017-08-31
Report date
2018-02-07
Termination date
2019-08-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0415-2018