Cervical Cage Trial Kit Recalled for Incorrect Size Labeling
restor3d Inc. is recalling 14 units of its Non-Sterile Double Ended Trial Kit because the product was labeled as Small Footprint when it is actually Medium. The lot was distributed nationwide across seven states.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall involving a labeling error on a medical device. No illnesses, injuries, or adverse events have been reported. The hazard is theoretical—a mislabeled surgical instrument that could be selected incorrectly—but no harm has occurred.
Plain-English summary
restor3d Inc. is recalling 14 units of its Non-Sterile Double Ended Trial Kit, Small Footprint model (6110-N01-KTS01), for the Cervical Cage. The product is an orthopedic manual surgical instrument used in spinal procedures.
The lot (2022030005) was labeled as "Small Footprint" when the actual product is Medium. This labeling discrepancy could lead to selection of an incorrectly sized trial kit, potentially affecting surgical outcomes if the wrong size is used during the cervical cage procedure.
The affected lot was distributed nationwide to healthcare facilities in Kentucky, North Carolina, New Jersey, Texas, Indiana, Virginia, and Alabama.
Healthcare providers and facilities that received this product should immediately verify the actual product size, correct their records and labeling, and contact restor3d Inc. for replacement or clarification if needed.
The recalled product
- Product
- Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual surgical instrument
- Manufacturer
- restor3d Inc.
- Hazard
- mis-labeling
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model: 6110-N01-KTS01 Lot: 2022030005 UDI: 00840097504506
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- HighMedtronic DLP Retrograde Cannula cardiopulmonary bypass catheter
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27
- HighPhilips Azurion X-Ray Systems Table Movement Control Defect Recall
FDA (Devices) · 2026-05-27