Exactech, Inc. Equinoxe Humeral Stem, Primary, Press Fit, 11mm Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
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.
Products Sold
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.
Exactech, Inc. is recalling Equinoxe Humeral Stem, Primary, Press Fit, 11mm due to Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, KS, OH
Page updated: Jan 10, 2026