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U.S. Department of Health and Human Services

Class 2 Device Recall Equinoxe Humeral Stem

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  Class 2 Device Recall Equinoxe Humeral Stem see related information
Date Initiated by Firm November 09, 2020
Create Date January 22, 2021
Recall Status1 Open3, Classified
Recall Number Z-0884-2021
Recall Event ID 86760
510(K)Number K042021  
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
Product Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Code Information Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407. 
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact
352-377-1140
Manufacturer Reason
for Recall		 Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
FDA Determined
Cause 2		 Employee error
Action Exactech distributed the recall notice titled, "URGENT PRODUCT RECALL NOTICE" to consignees in possession of affected inventory in the US and Australia on November 9, 2020 via email. In order to comply with the notice, 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 attached Recall Inventory Response Form to Exactech.
Quantity in Commerce 14 devices
Distribution Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
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 = HSD and Original Applicant = EXACTECH, INC.
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