Recall Z-1957-2013
SpineFrontier, Inc. · initiated May 9, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Invue Solid Driver, Tipped, AO. Part Number: 11-70083. Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
Codes / lots: Lot Number: 011836-0001, 011981-001
Reason for recall
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
FDA-determined cause: Device Design
Action taken
On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.
Details
- Recall number
- Z-1957-2013
- Initiated
- May 9, 2012
- Posted by FDA
- August 13, 2013
- Terminated
- January 10, 2014
- Product code
- HXX – Screwdriver
- Quantity
- 9
- Distribution
- Distributed in DC and the states of MA, and OK.
- Recalling firm
- SpineFrontier, Inc., Beverly, MA