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
This recall has been terminated (originally issued January 12, 2010).
- Company
- Medtronic Sofamor Danek Usa Inc
- Recall Initiated
- December 7, 2009
- Posted
- January 12, 2010
- Terminated
- January 14, 2011
- Recall Number
- Z-0606-2010
- Quantity
- 199 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.
Distribution
Nationwide distribution, and the Netherlands
Lot / Code Info
All Codes
Root Cause
Device Design
Action Taken
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.
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