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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 Stemsee related information
Date Initiated by FirmNovember 09, 2020
Create DateJanuary 22, 2021
Recall Status1 Open3, Classified
Recall NumberZ-0884-2021
Recall Event ID 86760
510(K)NumberK042021 
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
ProductEquinoxe 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
ActionExactech 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 Commerce14 devices
DistributionDistributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSD
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