CLASS II ONGOING Device recall · Reported 23 Sep 2026 · FDA Enforcement Report

Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) recalled

restor3d is recalling Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), distributed nationwide in the US. The recall was initiated on 27 Jul 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSystem Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.

Quantity recalled2

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-3178-2026
FDA event ID: 99512
Recalling firm: restor3d, Durham, NC
Classification: Class II
Status: Ongoing
Recall initiated: 27 Jul 2026
FDA classified: 16 Sep 2026
Reported: 23 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

27 Jul 2026	Recall initiated by company
16 Sep 2026	Classified by FDA	+51 days
23 Sep 2026	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

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

Where it was distributed

US Nationwide distribution in the states of FL, CO.

Nationwide Colorado Florida

Questions about this recall

Why was it recalled?

Which lots are affected?

System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.

Where was it sold?

US Nationwide distribution in the states of FL, CO.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 29 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from restor3d

All 5

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
11 May 2022Device	CLASS II	Evans Wedge Disposable Trials, Large Footprint Thickness recalled	restor3d	Other	Nationwide
11 May 2022Device	CLASS II	Non-Sterile Double Ended Trial Kit, Small Footprint recalled by restor3d	restor3d	Other	Nationwide
11 May 2022Device	CLASS II	Evans Wedge Disposable Trials, Medium Footprint Thickness recalled	restor3d	Other	Nationwide

Other Other Medical Devices recalls

All 13,817

Reported	Class	Recall	Company	Reason	Where
23 Sep 2026Device	CLASS II	Convenience kits Cataract Pack DYNJ59881A recalled by Medline Industries	Medline Industries	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Percutaneous Insertion Kit (PIK), dilator set recalled	Maquet Cardiopulmonary	Sterility	Nationwide
23 Sep 2026Device	CLASS II	Blood Culture Collection Venipuncture Kit 20/Cs recalled	Medical Action Industries Inc. 306	Sterility	Nationwide
23 Sep 2026Device	CLASS II	CADD Yellow Medication Cassette Reservoir with NRFit connector US recalled	ICU Medical	Packaging Defects	Nationwide
23 Sep 2026Device	CLASS II	Aisys, Datex-Ohmeda anesthesia system recalled	Datex-Ohmeda	Device Malfunction	Nationwide