Medtronic Sofamor Danek Extended Length Trocar, Item No.: 7578013, Mat'l: Stainless Steel, non-sterile, Rx only, Trocars
FDA device recall Z-0606-2010 · posted 2010-01-12 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek USA Inc
- Reason for recall
- The Trocar may not fully engage with the Rod Inserter or may prematurely disengage.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 199 units
- Distribution
- Nationwide distribution, and the Netherlands
- Date initiated
- 2009-12-07
- Date posted
- 2010-01-12
- Date terminated
- 2011-01-14
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.