Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile,
FDA device recall Z-0411-2007 · posted 2007-02-08 · Terminated
Recall details
- Recalling firm
- Medtronic Sofamor Danek Instrument Manufacturing
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNI
- Quantity affected
- 58 units
- Distribution
- Worldwide, including USA, the Netherlands, Canada, Australia, and the Bahamas.
- Date initiated
- 2006-12-18
- Date posted
- 2007-02-08
- Date terminated
- 2007-07-16
- Location
- Bartlett, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MSD SILO SPINAL SYSTEM (K042210) | Medtronic Sofamor Danek | 2004-11-04 |