Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
This recall has been terminated (originally issued June 5, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- May 10, 2008
- Posted
- June 5, 2013
- Terminated
- October 8, 2014
- Recall Number
- Z-1482-2013
- Quantity
- 10
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
Distribution
Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
Lot / Code Info
Lot number: 20856
Root Cause
Process design
Action Taken
Firm states they notified consignees of recall between 5/10/08 and 5/22/2008. Zero product is currently in distribution.
More recalls by Spinefrontier, Inc.
SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique; Part Number: DOC80023...
Apr 21, 2015
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion...
May 7, 2014