FDA-Device2015-11-18Class II
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Ceterix Orthopedics, Inc.
Hazard
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
Sold states
Nationwide Distribution
Affected count
1364 units
Manufactured in
959 Hamilton Ave, N/A, Menlo Park, CA, United States
Products
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0250-2016Don't want to check this manually?
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