Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) recall
restor3d Inc. recalled Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) on September 23, 2026 because of ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery. It was sold nationwide.
Why it was recalled
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
What's recalled
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Quantity: 2
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- restor3d Inc., Durham, NC
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
US Nationwide distribution in the states of FL, CO. - Status
- Ongoing
- Recall number
- Z-3178-2026
- Source
- U.S. Food and Drug Administration
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