Neocis Gen 2 Anterior Chairside Splint Recalled for Mislabeled Packaging
Neocis Inc. is recalling 50 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected products are distributed nationwide.
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: The recall is classified as FDA Class II and involves a minor labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Neocis Inc. is recalling 50 units of the DRW-0742-01 Gen 2 Anterior Chairside Splint LLUR (lower left-upper right). These medical devices are intended to assist in the planning and surgical phases of dental implantation surgery. The recall is being conducted because the products may be mislabeled.
The affected units are associated with Work Order (lot) 1623. The products were distributed nationwide, including in the states of Arizona, California, Florida, New York, and New Hampshire.
Healthcare professionals and patients who have these specific splints should stop using them and contact Neocis Inc. for further instructions regarding the mislabeling issue.
The recalled product
- Product
- DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
- Manufacturer
- Neocis Inc.
- Hazard
- Affected units
- 50
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)
- Work Order (lot): 1623
Distribution
Part of a larger recall action
This product is one of 3 recalled by Neocis 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.
See all 3 products in this recall →Related recalls
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