Neocis Dental Chairside Splints Recalled for Potential Mislabeling
Neocis Inc. is recalling specific dental chairside splints because they may be mislabeled. The recall covers 70 units 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 labeling error without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Neocis Inc. is recalling 70 units of Gen 2 Posterior Chairside Splints (LLUR) and LLUR Anterior Chairside Splints. The recall is due to the possibility that these products are mislabeled. The affected products are intended to assist in the planning and surgical phases of dental implantation surgery.
The recall includes Work Orders 1619 and 1620. These products were distributed nationwide, including in Arizona, California, Florida, New York, and New Hampshire. The source text does not specify the exact number of units distributed in each state or the specific dates of distribution.
Consumers and healthcare providers should stop using the affected splints and contact Neocis Inc. for further instructions. The recall is classified as Class II by the FDA, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- DRW-0739-01: Gen 2 Posterior 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
- 70
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): 1619 and 1620
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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