Z-0250-2016 Class II Terminated
FDA device recall Z-0250-2016 was initiated by Ceterix Orthopedics, Inc. on October 13, 2015 and is designated Class II. Reason for recall: The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel. The recall status is terminated (terminated February 12, 2016). Affected quantity: 1364 units.
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.