Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Only Provided non Sterile.
This recall has been terminated (originally issued June 1, 2016).
- Company
- Orthofix, Inc
- Recall Initiated
- April 27, 2016
- Posted
- June 1, 2016
- Terminated
- November 23, 2016
- Recall Number
- Z-1881-2016
- Quantity
- 36 units
- Firm Location
- Lewisville, TX
- Official Source
- View on FDA website ↗
Reason for Recall
There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
Distribution
KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
Lot / Code Info
All lots
Root Cause
Device Design
Action Taken
Affected distributors will be provided a written notification of field correction via USPS Certified Mail or FedEx on 4/27/16. Distributors will be additionally instructed to provide field correction notifcations to hospitals, surgeons, or other distributors that they may have further ditributed the product to.
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