Ceterix Disposable Knot Pusher Recalled for High Cut Force
Ceterix Orthopedics is recalling 96 units of the Disposable Knot Pusher / Suture Cutter because nonconforming blades may require higher than specified cut force.
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 involves a functional defect (higher cut force) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Ceterix Orthopedics, Inc. is recalling 96 units of the Ceterix Disposable Knot Pusher / Suture Cutter (Model# CTX-C001), an orthopedic arthroscopic accessory. The recall is due to possible nonconforming blades that may result in a higher than specified cut force required to cut the suture.
The affected product is identified by Lot#M180018 and was distributed in the United States. This recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare providers and consumers should stop using the affected product and contact Ceterix Orthopedics, Inc. for further instructions.
The recalled product
- Product
- Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
- Manufacturer
- Ceterix Orthopedics, Inc.
- Hazard
- Affected units
- 96
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)
- Lot#M180018
Distribution
Distribution scope not specified by the agency.
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