Ceterix NovoCut Suture Manager Recalled for Suture Cutting Risk
Ceterix Orthopedics is recalling 1,364 NovoCut Suture Manager devices because they may cut sutures during knot tensioning, causing knots to unravel.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (surgical suture failure) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ceterix Orthopedics, Inc. is recalling 1,364 units of the NovoCut Suture Manager (catalog number CTX-001). The device is intended for use in arthroscopic surgery in general and plastic surgery. The recall covers specific lot numbers: M150016, M150056, M150078, M150105, M150136, M150182, M150185, M150202, M150207, M150225, and M150239.
The recall was initiated because the device may cut the suture during the knot tensioning process. This defect may cause the suture knot to unravel. The affected units were distributed nationwide.
The U.S. Food and Drug Administration (FDA) has classified this recall as Class II. Healthcare providers and facilities should stop using the affected devices and contact Ceterix Orthopedics, Inc. for further instructions or replacement.
The recalled product
- Product
- NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
- Manufacturer
- Ceterix Orthopedics, Inc.
- Affected units
- 1,364
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)
- Ceterix catalog number CTX-001
Distribution
Distributed nationwide across the United States.
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