Recall Z-0606-2010 ยท LXH Orthopedic Manual Surgical Instrument
Medtronic Sofamor Danek USA Inc
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
| Date | Jan 12, 2010 (initiated Dec 7, 2009) |
| Status | Terminated |
| Reason | The Trocar may not fully engage with the Rod Inserter or may prematurely disengage. |
| Root cause | Device Design |
| 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. |
| Quantity | 199 units |
| Distribution | Nationwide distribution, and the Netherlands |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.