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Terminated

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

FDA Recall Z-0250-2016 · Posted 2015-11-09

Recalling FirmCeterix Orthopedics, Inc.
Recall StatusTerminated
Product CodeNBH
Date Initiated2015-10-13
Date Terminated2016-02-12
Product Quantity1364 units

Reason for Recall

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

Firm 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: [email protected]. For questions regarding this recall call 650-396-3478.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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