Exactech Humeral Augmented Tray (HAT) Trials Recall: Retaining Ring May Disengage
Exactech recalls HAT trials for KIT-321HAT that may have a retaining ring that disengages during use. Affected items include specific catalog numbers and lots. Consumers should check their product details.
Use caution until it’s fixed
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
Contact the company
What happened, in plain English
Exactech is recalling Humeral Augmented Tray (HAT) trials that are part of KIT-321HAT. The recall is due to a potential risk that the retaining ring could disengage during use, which might lead to complications in orthopedic surgery. Read more at govinfonow.com/recall/62580-exactech-humeral-augmented-tray-hat-trials-recall-retaining-ring-may.
Source Summary by GovInfoNow · govinfonow.com/recall/62580-exactech-humeral-augmented-tray-hat-trials-recall-retaining-ring-may · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1977-2021
Cite this page
“Exactech Humeral Augmented Tray (HAT) Trials Recall: Retaining Ring May Disengage.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62580-exactech-humeral-augmented-tray-hat-trials-recall-retaining-ring-may. Based on FDA recall #Z-1977-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1977-2021%22&limit=1).
Why it’s dangerous
The HAT trial contains a retaining ring that has shown potential to disengage during use. This could cause the tray to become loose or misaligned, potentially leading to complications in the surgical procedure.
Who’s affected
Orthopedic surgeons and medical professionals who use Exactech's Humeral Augmented Tray trials for KIT-321HAT implants are most at risk. Patients receiving these implants may also be affected if the trays are used incorrectly.
How to tell if you have this one
Check for the specific catalog numbers: 321-00-01 to 321-00-22. Also look for the lot numbers listed: 279244001 to 279244006. These items were sold as part of the KIT-321HAT package.
- Brand
Exactech- Category
Medical device
What to do — step by step
Check Product Details
Identify the catalog number and lot number on your HAT trial to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 6 states.
FDA distribution: “US Nationwide distribution in the states of AZ, CO, FL, NY, SC, and TN. There was no foreign/government/military distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Colorado, Florida, New York, South Carolina, Tennessee.
Recall timeline
FDA published this recall 57 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
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-1977-2021 (May 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1977-2021 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.