FDA Medical Device Recalls (openFDA)
Ceterix Orthopedics, Inc.: NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
- Recall number
- Z-0250-2016
- Recalling firm
- Ceterix Orthopedics, Inc.
- Product
- NovoCut Suture Manager; Ceterix catalog number CTX-001. General and Plastic Surgery: Intended for use in arthroscopic surgery.
- Status
- Terminated
- Initiated
- 2015-10-13
- Posted
- 2015-11-09
- Terminated
- 2016-02-12
- 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
- Lot, serial or model codes
- Ceterix catalog number CTX-001; Lot numbers: M150016 M150056 M150078 M150105 M150136 M150182 M150185 M150202 M150207 M150225 M150239.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NBH
- Firm FEI
- 3009131204
- Firm city
- Menlo Park
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28