Z-0884-2021Class II

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Name: Z-0884-2021 Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Creator: Exactech, Inc.
Published: 2020-11-09
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2020-11-09 / Open, Classified / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of Equinoxe Humeral Stem, Primary, Press Fit, 11mm on 2020-11-09. FDA classified it as Class II and gives the reason as "Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0884-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-11-09
Posted: 2021-01-22
Recalling firm: Exactech, Inc.
Product: Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Product code: HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Reason for recall: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0884-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0884-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-01-27	2021-01-21

Product code HSD

K042021Class IIExactech Equinoxe Shoulder SystemExactech, Inc. / cleared 2004-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)