Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/clinic).
This recall has been terminated (originally issued October 19, 2006).
- Recall Initiated
- August 1, 2006
- Posted
- October 19, 2006
- Terminated
- April 4, 2007
- Recall Number
- Z-0050-2007
- Quantity
- 9 units
- Firm Location
- Bartlett, TN
- Official Source
- View on FDA website ↗
Reason for Recall
Bone reamer may not have a cutting surface on the tip.
Distribution
Nationwide
Lot / Code Info
Lot Nos.: CN04J012, CN06A003
Root Cause
Other
Action Taken
The firm notified its hospital consignees by letter dated 08/01/2006. The letter requested cessation of use and return.