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restor3d Inc. FDA Recalls

5 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006Class IIJul 27, 2026Ankle implantation systems were packaged with incorrect pati	Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in:	Class IIDevices	Jul 27, 2026
Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog NumClass IIJun 30, 2026Due to incorrect machining of peripheral screw hole resultin	Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peri	Class IIDevices	Jun 30, 2026
Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instruClass IIMar 30, 2022During re-work of disposable instruments to relabel for 4-ye	During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got	Class IIDevices	Mar 30, 2022
Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrumentClass IIMar 30, 2022During re-work of disposable instruments to relabel for 4-ye	During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got	Class IIDevices	Mar 30, 2022
Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Class IIMar 30, 2022Product labeled incorrectly. The lot was labeled with Small	Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.	Class IIDevices	Mar 30, 2022

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