Recall Z-0250-2016
Ceterix Orthopedics, Inc. · initiated October 13, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
Codes / lots: Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.
Reason for recall
The NovoCut Suture Manager device may cut the suture during knot tensioning and this may cause the suture knot to unravel.
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-0250-2016
- Initiated
- October 13, 2015
- Posted by FDA
- November 9, 2015
- Terminated
- February 12, 2016
- Product code
- NBH – Accessories, Arthroscopic
- Quantity
- 1364 units
- Distribution
- Nationwide Distribution
- Recalling firm
- Ceterix Orthopedics, Inc., Menlo Park, CA