Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct. Rx Onl
FDA device recall Z-1881-2016 · posted 2016-06-01 · Terminated
Recall details
- Recalling firm
- Orthofix, Inc
- 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.
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HXX
- Quantity affected
- 36 units
- Distribution
- KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
- Date initiated
- 2016-04-27
- Date posted
- 2016-06-01
- Date terminated
- 2016-11-23
- Location
- Lewisville, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System (K153428) | Orthofix, Inc. | 2016-01-29 |