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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 14
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
Part of a larger recall action
This product is one of 3 recalled by restor3d Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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