FDAClass IISeptember 5, 2018

Ceterix Disposable Knot Pusher / Suture Cutter recall

Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.

Why was Ceterix Disposable Knot Pusher / Suture Cutter recalled?

Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#M180018

Product
Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.
Recalling firm
Ceterix Orthopedics, Inc.
Quantity
96 units
Distribution
United States distribution.
Recall date
September 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls