Reported Nov 18, 2015 · Terminated
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic…
Ceterix Orthopedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ceterix Orthopedics, Inc. · 959 Hamilton Ave · Menlo Park, CA · 94025-1431
Is this the product you have?
- NovoCut Suture Manager; Ceterix catalog number CTX-001
- General and Plastic SurgeryIntended for use in arthroscopic surgery
- Lot codes and dates
- Ceterix catalog number CTX-001
- Lot numbers
M150016M150056M150078M150105M150136M150182M150185M150202M150207M150225M150239
- Amount recalled
- 1364 units
Where it was sold
- Nationwide
Why it was recalled
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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