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Terminated

Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

FDA Recall Z-0307-2021 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodePHX
Date Initiated2020-09-25
Date Terminated2023-05-01
Product Quantity25 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.

K101909EXACTECH EQUINOXE, PLATFORM FRACTURE STEMExactech, Inc. · 2010-08-02K092900EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEMExactech, Inc. · 2010-01-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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