Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

FDA Recall Z-3178-2026 · Posted 2026-09-16

Recalling Firmrestor3d Inc.
Recall StatusOpen, Classified
Product CodeOYK
Date Initiated2026-07-27
Product Quantity2

Reason for Recall

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.

Firm Action

On 7/28/2026, recall notices were emailed to customers who were asked to do the following: 1) Segregate and return affected devices. 2) Complete and return the response form. If additional questions, contact firm at 984-201-2310

Root Cause

Labeling Change Control

Distribution Pattern

US Nationwide distribution in the states of FL, CO.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K223326Axiom PSR SystemRestor3D · 2023-03-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑