Exactech Equinoxe Shoulder System: Potential Mislabeling Risk
Exactech recalls Equinoxe Shoulder System products with catalog #314-13-03 and serial numbers 5013050-501: potential mislabeling could lead to incorrect use in skeletally mature patients.
Lower-risk recall
Potentially mislabeled.
Contact the company
What happened, in plain English
Exactech is recalling specific Equinoxe Shoulder System products due to potential mislabeling. This could mean the products might be used incorrectly for patients who are not skeletally mature, which is unsafe. Read more at govinfonow.com/recall/73095-exactech-equinoxe-shoulder-system-potential-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/73095-exactech-equinoxe-shoulder-system-potential-mislabeling-risk · Updated September 18, 2026 · FDA enforcement record: FDA #Z-0414-2018
Cite this page
“Exactech Equinoxe Shoulder System: Potential Mislabeling Risk.” GovInfoNow, updated September 18, 2026. https://govinfonow.com/recall/73095-exactech-equinoxe-shoulder-system-potential-mislabeling-risk. Based on FDA recall #Z-0414-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0414-2018%22&limit=1).
Why it’s dangerous
The products are labeled for use in skeletally mature individuals with certain conditions. If mislabeled, they might be used on patients who are not skeletally mature, which could lead to unsafe outcomes.
Who’s affected
Patients who received the recalled Equinoxe Shoulder System products with catalog number 314-13-03 and serial numbers 5013050-5013079. Surgeons and medical staff who use these products are most at risk of administering them to the wrong patient group.
How to tell if you have this one
Check for catalog number 314-13-03 and serial numbers 5013050 to 5013079 on the product packaging. The products are intended for use in skeletally mature patients with specific medical conditions.
- Brand
Exactech- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- 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
| Recall number | Product, codes & lots |
|---|---|
| Z-0414-2018 | Equinoxe Cage, Glenoid, Alpha, Small 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.; Catalog #: 314-13-03 Serial Range: 5013050 - 5013079 |
| Z-0415-2018 | 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.; Catalog #: 314-13-03 Serial Range: 5013020 - 5013049 |
What to do — step by step
Check Product Label
Look for catalog number 314-13-03 and serial numbers 5013050-5013079 on the product packaging.
Where it went and when
Where it was distributed
Distributed in 14 states and Puerto Rico, and outside the U.S.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, California, Colorado, Florida, Georgia, Maine, Minnesota, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Virginia, Wisconsin.
Recall timeline
FDA terminated this recall 23 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0414-2018 (August 31, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0414-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.