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U.S. Department of Health and Human Services

Class 2 Device Recall Kinos Axiom Total Ankle System with Axiom PSR, Flatcut (Cut Guide)

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 Class 2 Device Recall Kinos Axiom Total Ankle System with Axiom PSR, Flatcut (Cut Guide)see related information
Date Initiated by FirmJuly 27, 2026
Date PostedSeptember 16, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3178-2026
Recall Event ID 99512
510(K)NumberK223326 
Product Classification Ankle arthroplasty implantation system - Product Code OYK
ProductKinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Code Information System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
FEI Number 3014833750
Recalling Firm/
Manufacturer		 restor3d Inc.
4001 E Nc 54 Hwy
Suite 3160
Durham NC 27709
For Additional Information ContactBrianna Gabbard
786-521-0501
Manufacturer 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 Determined
Cause 2		Labeling Change Control
ActionOn 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 Commerce2
DistributionUS Nationwide distribution in the states of FL, CO.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OYK
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