FDA Recall
Terminated
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Recall: Z-0459-2021
·
Initiated October 6, 2020
Recall
- Recall Number
- Z-0459-2021
- Event Number
- 86630
- Firm
- Exactech, Inc.
- FEI Number
- 1038671
- Product Code
- KWS
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- October 6, 2020
- Terminated
- November 13, 2023
- Address
- 2320 NW 66th Ct, Gainesville, FL, 32653-1630
Description
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Reason
The product may be mislabeled.
Action
Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -Immediately cease distribution or use of this product. -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the attached Recall Inventory Response Form to Exactech.
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
Quantity
69 devices