Recall Z-1482-2013
SpineFrontier, Inc. · initiated May 10, 2008
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot number: 20856
Reason for recall
During two separate occasions an impactor plate on the handle broke off while being struck by a mallet.
FDA-determined 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.
Details
- Recall number
- Z-1482-2013
- Initiated
- May 10, 2008
- Posted by FDA
- June 5, 2013
- Terminated
- October 8, 2014
- Product code
- HWA – Impactor
- Quantity
- 10
- Distribution
- Worldwide distribution: US (nationwide) to states of: CO, MA, and TX; and country of: Jamaica.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA