Z-3178-2026Class II

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

Name: Z-3178-2026 Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Creator: restor3d Inc.
Published: 2026-07-27
License: https://open.fda.gov/license/

restor3d Inc. / initiated 2026-07-27 / Open, Classified

FDA source

Recall record

Recall number: Z-3178-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-07-27
Posted: 2026-09-16
Recalling firm: restor3d Inc.
Product: Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Product code: OYK Ankle Arthroplasty Implantation System
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.
FDA root cause: Labeling Change Control
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
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of FL, CO.
Product codes and lots: System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3178-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3178-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-16

Product code OYK

K223326Class IIAxiom PSR SystemRestor3D / cleared 2023-03-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)