Equinoxe recallZ-0884-2021 · Exactech, Inc. · initiated Nov 9, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-0884-2021
- Status
- Open, Classified
- Initiated by the company
- Nov 9, 2020
- Recalling firm
- Exactech, Inc.
- Quantity
- 14 devices
- Product code
- HSD
- FDA submissions
- K042021
- Distribution
- Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Product description
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Code information (models, lots, serial 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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Equinoxe 300-01-11Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall44 reports
Product lines
Other devices under the same FDA submission
71 devices cleared under K042021 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Equinoxe 314-02-02Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall10 reports
- Equinoxe 314-02-14Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall8 reports
- Equinoxe 314-02-03Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall4 reports
- Equinoxe 314-02-13Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall4 reports
- Equinoxe 314-01-02Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall2 reports
- Equinoxe 314-01-13Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall2 reports
- Equinoxe 314-02-04Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall1 report
- Equinoxe 314-01-03Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
- Equinoxe 314-01-04Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
- Equinoxe 314-01-12Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
- Equinoxe 314-01-14Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
- Equinoxe 314-02-12Exactech, Inc. · Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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