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.
This recall has been terminated (originally issued August 13, 2013).
- Company
- Spinefrontier, Inc.
- Recall Initiated
- May 9, 2012
- Posted
- August 13, 2013
- Terminated
- January 10, 2014
- Recall Number
- Z-1957-2013
- Quantity
- 9
- Firm Location
- Beverly, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
Distribution
Distributed in DC and the states of MA, and OK.
Lot / Code Info
Lot Number: 011836-0001, 011981-001
Root 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.
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