Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plas
FDA device recall Z-1847-2015 · posted 2015-06-26 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- Reason for recall
- Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps.
- Action taken
- Consignees were notified via Urgent Medical Device Correction Notification on 5/26/15. The letter identified the affected product and described the issue. This field correction does not require the return of the subject products. Revised instructions for use are being provided to the identified consignees.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 15,798
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-05-26
- Date posted
- 2015-06-26
- Date terminated
- 2015-10-23
- Location
- Louisville, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.