Neocis Anterior Chairside Splints Recalled for Potential Mislabeling
Neocis, Inc. is recalling 100 units of Gen 2 Anterior Chairside Splints due to potential mislabeling. The affected units were distributed to facilities in 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: The recall is classified as FDA Class II, and the hazard is limited to potential mislabeling without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Neocis, Inc. is recalling 100 units of the DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left). These accessories are part of the Neocis Guidance System (NGS). The recall is associated with Work Order (Lot) Number 1573.
The recall was initiated because the LRUL and LLUR posterior chairside splints and the LLUR anterior chairside splints may be mislabeled. The affected units were distributed to facilities in Ohio, Florida, Connecticut, Massachusetts, Arizona, Pennsylvania, and New York.
Healthcare facilities should check their inventory for the specific lot number and product description. If the affected units are found, they should be removed from use and returned to Neocis, Inc. according to the company's instructions.
The recalled product
- Product
- DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
- Manufacturer
- Neocis, Inc.
- Hazard
- Affected units
- 100
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) Number 1573
Distribution
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