Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

FDA Recall Z-0012-2019 · Posted None

Recalling FirmExactech, Inc.
Recall StatusOpen, Classified
Product CodeKWT
Date Initiated2018-08-21
Product Quantity2 units

Reason for Recall

The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as intended.

Firm Action

The firm disseminated the field safety notice by email on 08/21/2018. The notice requested the following actions: " 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 Acknowledgment Form and Recall Inventory Response Form to Exactech.

Root Cause

Under Investigation by firm

Distribution Pattern

In the countries of Australia and France

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K063569EQUINOXE REVERSE SHOULDER SYSTEMExactech, Inc. · 2007-02-23

Official Source

View FDA Recall →

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

↑