Recall Z-0411-2007 ยท MNI Orthosis, Spinal Pedicle Fixation
Medtronic Sofamor Danek Instrument Manufacturing
Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufactured at: Bartlett, Tennessee, USA
| Date | Feb 8, 2007 (initiated Dec 18, 2006) |
| Status | Terminated |
| Reason | Due to a manufacturing error, the proximal end may deform causing the protrusions that engage the associated implant to break off of the instrument during use. |
| Root cause | Other |
| Action | The firm sent out the recall letter via Federal Express to direct consignees on 12/18/2006. The letter explained the problem, requested discontinuation of use and stated that sales representatives would be coordinating the retrieval and replacement of the device. |
| Quantity | 58 units |
| Distribution | Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042210 | MSD SILO SPINAL SYSTEM Medtronic Sofamor Danek, Nov 4, 2004 |