—#87259

Product

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 product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All Codes

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Medtronic Sofamor Danek USA Inc
Address: 1800 Pyramid Place, Memphis, Tennessee 38132

Distribution

Distribution pattern: Nationwide distribution, and the Netherlands

Timeline

Recall initiated: 2009-12-07
Posted by FDA: 2010-01-12
Terminated: 2011-01-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87259. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.