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New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self
Recalled September 7, 2022 · FDA recall Z-1649-2022 · New Standard Device
Hazard
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery. · FDA Class II
Units
410 total devices
Sold at
U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None
Description
Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.
Product
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
Manufacturer(s)
New Standard Device Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →