The Recall Desk
HighFDA (Devices)·Z-3178-2026·Announced 2026-09-23

restor3d Recalls Kinos Axiom Total Ankle Systems with Incorrect Cutting Guides

restor3d Inc. is recalling two Kinos Axiom Total Ankle Systems because they were packaged with incorrect patient-specific cutting guides, which may lead to surgical complications.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a defect that may lead to significant surgical complications, including implant loosening and the need for revision surgery, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

restor3d Inc. is voluntarily recalling two units of the Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006. The recall was initiated because the ankle implantation systems were packaged with incorrect patient-specific cutting guides.

The use of incorrect cutting guides may result in delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening or migration, or the need for revision surgery. The affected units have System Serial Numbers 18169 and 18059, and are associated with REF: 5831-9006, Lot: D-788, and UDI-DI: 00840097509945.

The products were distributed nationwide in the United States, specifically in the states of Florida and Colorado. Healthcare providers and patients should contact restor3d Inc. for further instructions regarding the recall and potential replacement or repair of the affected devices.

The recalled product

Product
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Manufacturer
restor3d Inc.
Category
Medical Device — Orthopedic Implants
Hazard
Affected units
2

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Related recalls

Same manufacturer · restor3d Inc.

See all →