Equinoxe 44mm Short Humeral Head recallZ-1459-2015 · Exactech, Inc. · initiated Feb 13, 2015
Class II Terminated All recalls posted in April 2015
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
Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
FDA root cause category: Labeling mix-ups
What the company is doing
Exactech Agents sent a Product Recall Advisory Notice dated February 12, 2015 by mailed to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the Recall Inventory Respponse form and return it to Exactech, per the instructions provided on the notice.
Recall details
- Recall number
- Z-1459-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 13, 2015
- Posted by the FDA
- Apr 20, 2015
- Recalling firm
- Exactech, Inc.
- Quantity
- 112 devices
- Product code
- KWS
- FDA submissions
- K042021
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
Product description
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Code information (models, lots, serial numbers)
Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
Other devices under the same FDA submission
72 devices cleared under K042021 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Equinoxe 300-01-11Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall44 reports
- 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
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 18, 2026. Text above is shown as published by the FDA.
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