Z-3178-2026 Class II Ongoing
FDA device recall Z-3178-2026 was initiated by restor3d Inc. on July 27, 2026 and is designated Class II. 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 alignm… The recall status is ongoing. Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 27, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
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.
Distribution Pattern
US Nationwide distribution in the states of FL, CO.
Code Information
System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.