Neocis Dental Chairside Splints Recalled for Potential Mislabeling
Neocis Inc. is recalling 70 units of Gen 2 Posterior Chairside Splints due to potential mislabeling. The affected products are used in dental implantation surgery.
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 (mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Neocis Inc. is recalling 70 units of the DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left). These medical devices are intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
The recall was initiated because the LRUL and LLUR posterior chairside splints and LLUR anterior chairside splints may be mislabeled. The affected units are associated with Work Order (lot) numbers 1616, 1621, and 1622.
The products were distributed nationwide in the United States, including in the states of Arizona, California, Florida, New York, and New Hampshire. Consumers and healthcare providers should stop using the affected products and contact Neocis Inc. for further instructions.
The recalled product
- Product
- DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - 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 (3)
- Work Order (lot): 1616
- 1621
- and 1622
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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