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Terminated

Ceterix Disposable Knot Pusher / Suture Cutter; NovoCut Suture Manager. Model# CTX-C001. orthopedic arthroscopic accessory.

FDA Recall Z-2945-2018 · Posted None

Recalling FirmCeterix Orthopedics, Inc.
Recall StatusTerminated
Product CodeNBH
Date Initiated2018-05-16
Date Terminated2020-08-24
Product Quantity96 units

Reason for Recall

Possible nonconforming blades may result in a higher than specified cut force required to cut the suture.

Firm Action

Ceterix Orthopaedics notified customers via an "Urgent Field Safety Notice: for NovoCut Suture Manager. The letter dated May 16, 2018 provided the following: Details on affected devices, Description of the problem, Risks to Health, Actions to be taken by the customer, and Contact reference person.

Root Cause

Nonconforming Material/Component

Distribution Pattern

United States distribution.

Official Source

View FDA Recall →

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

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