Home / Recalls / Ceterix Orthopedics, Inc. / Z-0250-2016

Z-0250-2016 Class II Terminated

Recalled by Ceterix Orthopedics, Inc. — Menlo Park, CA

Recall Details

Product Type: Devices
Report Date: November 18, 2015
Initiation Date: October 13, 2015
Termination Date: February 12, 2016
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1364 units

Product Description

NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.

Reason for Recall

The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.

Distribution Pattern

Nationwide Distribution

Code Information

Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.