FDA recall Z-0459-2021

Product

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

Reason for recall

The product may be mislabeled.

Distribution

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

Key facts

Status

Terminated

Initiation date

2020-10-06

Report date

2020-11-25

Termination date

2023-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gainesville, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0459-2021