Recall Z-0307-2021 ยท PHX Shoulder Prosthesis, Reverse Configuration
Exactech, Inc.
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
| Date | Sep 25, 2020 |
| Status | Terminated |
| Reason | The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem. |
| Root cause | Process control |
| Action | The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020. 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 Recall Inventory Response Form to Exactech. |
| Quantity | 25 devices |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil. |
| FDA record | Open on fda.gov |