Exactech Equinoxe Platform Fracture Stem Left Stem Recall: Incorrect Laser Marking
Exactech recalls 6.5mm Left Equinoxe Platform Fracture Stems with incorrect laser marking that could lead to improper use in spinal surgery.
Lower-risk recall
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Contact the company
What happened, in plain English
Exactech is recalling specific 6.5mm left Equinoxe Platform Fracture Stems that may be incorrectly marked as right stems. This could cause improper use during spinal surgery if the wrong stem is installed. Read more at govinfonow.com/recall/64145-exactech-equinoxe-platform-fracture-stem-left-stem-recall-incorrect-laser.
Source Summary by GovInfoNow · govinfonow.com/recall/64145-exactech-equinoxe-platform-fracture-stem-left-stem-recall-incorrect-laser · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0307-2021
Cite this page
“Exactech Equinoxe Platform Fracture Stem Left Stem Recall: Incorrect Laser Marking.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64145-exactech-equinoxe-platform-fracture-stem-left-stem-recall-incorrect-laser. Based on FDA recall #Z-0307-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0307-2021%22&limit=1).
Why it’s dangerous
The stem may be laser marked as a right stem instead of left. This could lead to improper installation during spinal surgery, potentially causing complications. However, the hazard is not described as causing serious injury in normal use.
Who’s affected
Orthopedic surgeons and medical professionals who use these stems for spinal fusion procedures are most at risk if they install the wrong stem. Patients receiving this specific stem during surgery may be affected.
How to tell if you have this one
Check for the model number 304-21-07 and serial numbers between 4968615-4968627 or 4952421-4952432. The product is intended for cemented spinal fusion procedures.
- 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 - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0307-2021 | Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.; Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432 | 25 devices |
| Z-0308-2021 | Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.; Catalog: 304-22-07; Serial Range: 4971292-4971303 | 12 devices |
What to do — step by step
Check Product Marking
Verify the laser marking on the stem to ensure it is labeled as a left stem.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 8 states.
FDA distribution: “Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Colorado, Florida, Indiana, Kentucky, New York, Ohio, Puerto Rico, Texas.
Recall timeline
FDA terminated this recall 2.6 years 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-0307-2021 (September 25, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0307-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 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.