Exactech Equinoxe Cage Glenoid Recall: Possible Mislabeling Risk
Exactech recalls specific model Equinoxe Cage Glenoid implants due to potential mislabeling. Affected units include serial numbers listed in the recall notice. Consumers should verify their product against the provided list.
Lower-risk recall
The product may be mislabeled.
Contact the company
What happened, in plain English
Exactech is recalling a specific type of surgical implant (Equinoxe Cage Glenoid, Posterior Augment, Left, Medium) because it may be mislabeled. This means the product could be incorrectly labeled, which might lead to improper use or complications during surgery. Read more at govinfonow.com/recall/64116-exactech-equinoxe-cage-glenoid-recall-possible-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/64116-exactech-equinoxe-cage-glenoid-recall-possible-mislabeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0459-2021
Cite this page
“Exactech Equinoxe Cage Glenoid Recall: Possible Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64116-exactech-equinoxe-cage-glenoid-recall-possible-mislabeling-risk. Based on FDA recall #Z-0459-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0459-2021%22&limit=1).
Why it’s dangerous
The product may be mislabeled, meaning the implant could be incorrectly identified as a different size or type. This could lead to improper surgical placement or complications during the procedure if the wrong implant is used.
Who’s affected
Surgical patients who received the specific Equinoxe Cage Glenoid implant with the listed serial numbers are affected. Patients using this implant for joint reconstruction are most at risk due to potential mislabeling.
How to tell if you have this one
Check if your implant has the model name 'Equinoxe Cage Glenoid, Posterior Augment, Left, Medium' and one of the listed serial numbers. The recall includes specific serial numbers provided in the official notice.
- 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
US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-0459-2021 | Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium; Catalog 314-13-23, Serial Numbers: 6262746 6262747 6262748 6262749 6262750 6262751 6262753 6262754 6262756 6262757 6262758 6262759 6262760 6262761 6262762 6262763 6142776 6142777 6142779 6142780 6142782 6142783 6142785 6142787 6142788 6142790 6142792 6142793 6142794 6142795 6142796 6142798 6142801 6142802 6142803 6142804 6130334 6130335 6130336 6130340 6130341 6130343 6130344 6130347 6130352 6130353 6130355 6130356 6130357 6130358 6130361 6130365 6130366 6130367 6130368 6147287 6147294 6147297 6147298 6147299 6147300 6147301 6147303 6147303 6147308 6147310 6147314 6147317 6147318 | 69 devices |
| Z-0460-2021 | Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium; Catalog 314-13-33, Serial Numbers: 6259572 6259573 6259575 6259577 6259578 6259579 6259583 6259584 6259587 6259588 6259590 6259591 6259592 6259594 6259595 6132993 6132994 6132995 6132996 6132997 6132998 6132999 6133000 6133002 6133003 6133005 6133008 6133009 6133010 6133011 6133013 6133014 6133017 6133020 6133021 6133023 6133029 6133030 6133031 6133032 | 40 devices |
What to do — step by step
Verify Your Product
Check the serial number on your implant against the list of affected serial numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed in 21 states, and outside the U.S.
FDA distribution: “US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Illinois, Indiana, Kentucky, Louisiana, Maine, Maryland, Minnesota, Nevada, New York, Ohio, Oklahoma, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA terminated this recall 3.1 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.
Questions people ask
Do I need to stop using this implant?
No, the recall is for potential mislabeling, not a safety hazard. You do not need to stop using it unless you have the specific serial numbers listed.
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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-0459-2021 (October 6, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0459-2021 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.