Recall Z-0250-2016 ยท NBH Accessories, Arthroscopic
Ceterix Orthopedics, Inc.
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
| Date | Nov 9, 2015 (initiated Oct 13, 2015) |
| Status | Terminated |
| Reason | The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel. |
| Root cause | Device Design |
| Action | Ceterix Orthopaedics sent an Urgent Field Safety notification letter dated October 13, 2015, to all affected sites. The product was identified, reason for recall explained and letter contains list of product lot numbers affected. Customers were instructed to identify and quarantine the affected product, contact Ceterix Orthopaedics to arrange a no cost return, and complete and return the attached acknowledgement form. Customers with questions were instructed to call 1-888-305-0615 or email: docs@ceterix.com. For questions regarding this recall call 650-396-3478. |
| Quantity | 1364 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.