FDA-Device2022-09-07Class II
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
New Standard Device Inc
Hazard
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Sold states
U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
Affected count
410 total devices
Manufactured in
4848 Research Dr, San Antonio, TX, United States
Products
Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1649-2022Don't want to check this manually?
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