Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
FDA Recall Z-0308-2021 · Posted None
Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodePHX
Date Initiated2020-09-25
Date Terminated2023-05-01
Product Quantity12 devices
Reason for Recall
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Firm 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.
Root Cause
Process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.