Equinoxe Cage, Glenoid, Alpha, Medium recallZ-0415-2018 · Exactech, Inc. · initiated Aug 31, 2017
Class II Terminated All recalls posted in January 2018
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
Potentially mislabeled.
FDA root cause category: Under Investigation by firm
What the company is doing
Consignees were sent a Recall Notice dated 8/31/2017 by mail informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions please call (800) 392-2832.
Recall details
- Recall number
- Z-0415-2018
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Aug 31, 2017
- Posted by the FDA
- Jan 18, 2018
- Recalling firm
- Exactech, Inc.
- Quantity
- 30
- Product code
- KWS
- FDA submissions
- K113309
- Distribution
- Worldwide distribution in the states of OH, WI, AZ, GA, VA, CA, OK, MN, TN, ME, CO, SC, FL, AL, and Puerto Rico and country of Switzerland
Product description
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
Code information (models, lots, serial numbers)
Catalog #: 314-13-03 Serial Range: 5013020 - 5013049
Other devices under the same FDA submission
27 devices cleared under K113309 — 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 314-13-03Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall51 reports
- Equinoxe 314-13-13Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall42 reports
- Equinoxe 314-13-02Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall39 reports
- Equinoxe 314-13-33Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall38 reports
- Equinoxe 314-13-14Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall32 reports
- Equinoxe 314-13-34Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall18 reports
- Equinoxe 314-13-23Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall13 reports
- Equinoxe 314-13-24Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall13 reports
- Equinoxe 314-13-22Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall10 reports
- Equinoxe 314-13-32Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall10 reports
- Equinoxe 314-13-15Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall8 reports
- Equinoxe 314-13-04Exactech, Inc. · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall6 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 78903).
- Z-0414-2018 · TerminatedEquinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of t…
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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