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.
The HAT trial contains a retaining ring that has shown the potential to disengage during use.
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.
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.
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.
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.
Identify the catalog number and lot number on your HAT trial to confirm if it is affected.
The recall is due to the potential for the retaining ring in the HAT trial to disengage during use, which could cause complications in orthopedic surgery.
Check for the specific catalog numbers (321-00-01 to 321-00-22) and lot numbers (279244001 to 279244006) listed in the recall notice.
The recall does not specify a remedy, so contact Exactech directly for further instructions.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1977-2021 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1977-2021 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
