FDA recall Z-2945-2018

Ceterix Orthopedics, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

United States distribution.

Key facts

Status
Terminated
Initiation date
2018-05-16
Report date
2018-09-05
Termination date
2020-08-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fremont, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2945-2018