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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe Reverse Drill Bit Kit

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  Class 2 Device Recall Equinoxe Reverse Drill Bit Kit see related information
Date Initiated by Firm August 21, 2018
Create Date October 03, 2018
Recall Status1 Open3, Classified
Recall Number Z-0012-2019
Recall Event ID 80996
510(K)Number K063569  
Product Classification Prosthesis, shoulder, non-constrained, metal/polymer cemented - Product Code KWT
Product Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00

Product Usage:
Shoulder surgery
Code Information Serial Numbers: 5214432, 5214445
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer 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.
FDA Determined
Cause 2		 Under Investigation by 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.
Quantity in Commerce 2 units
Distribution In the countries of Australia and France
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KWT and Original Applicant = EXACTECH, INC.
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