Durham, NC, United States
restor3d Inc. recalls
3 recalls recorded since 2018, most recently on 27 July 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 27 July 2026
- Reason
- 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
- US Nationwide distribution in the states of FL, CO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3178-2026
- Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Ongoing Class II Medical devices
- Recall started
- 30 June 2026
- Reason
- Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- Distribution
- U.S. Nationwide distribution in the state of Texas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2987-2026
- Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030; 1500-1035 Software Version: N/A - off-the-shelf hardware product Product Descripti
Terminated Class II Medical devices
- Recall started
- 30 March 2022
- Terminated
- 28 August 2023
- Reason
- During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
- Distribution
- US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1027-2022, Z-1026-2022, Z-1028-2022
- Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
- Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
- Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818). Orthopedic manual surgical instrument
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.