Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d Inc. · Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrum…
Open FDA's page for this record- Cfres ID
- 221721
- Product res number
- Z-3178-2026
- Event date initiated
- 2026-07-27
- Event date posted
- 2026-09-16
- Recall status
- Open, Classified
- Res event number
- 99512
- Product code
- OYK
- Product description
- Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
- Code info
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Firm FEI number
- 3014833750
- Recalling firm
- restor3d Inc.
- Address 1
- 4001 E Nc 54 Hwy
- Address 2
- Suite 3160
- City
- Durham
- State
- NC
- Postal code
- 27709
- Additional info contact
- Brianna Gabbard 786-521-0501
- Root cause description
- Labeling Change Control
- Product quantity
- 2
- Distribution pattern
- US Nationwide distribution in the states of FL, CO.
- 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.
- 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
- K numbers
- K223326
- Harmonized identifiers (openFDA)
- Device name
- Ankle Arthroplasty Implantation System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3110
- Device class
- 2
- K number
- K243173, K223326, K231585, K241148, K241326, K193432, K243174
- Registration number
- 3036756245, 3025603301, 3012275107, 3014833750, 3008650117, 1051526, 1424434, 3010470577, 1724955, 1057425, 3010667733, 1043534, 3033509898
- FEI number
- 3036756245, 3025603301, 3012275107, 3003142829, 3014833750, 3008650117, 3002795782, 1051526, 3010470577, 1000221916, 3010667733, 1043534, 3033509898