Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars used with the CD HORIZON LEGACY" Percutaneous Peek Spinal System

FDA Recall Z-0606-2010 · Posted 2010-01-12

Recalling FirmMedtronic Sofamor Danek USA Inc
Recall StatusTerminated
Product CodeLXH
Date Initiated2009-12-07
Date Terminated2011-01-14
Product Quantity199 units

Reason for Recall

The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.

Firm Action

On 12/7/2009, the Sales Representatives were notified by conference call and email regarding the recall. The recall notices were mailed directly to Risk Managers and Sales Representatives, with Recall Questionnaires and Confirmation forms included respectively, on 12/09/2009 with a delivery date of 12/10/09.

Root Cause

Device Design

Distribution Pattern

Nationwide distribution, and the Netherlands

Official Source

View FDA Recall →

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

↑